STERIS Corporation - Helping to provide a healthier today and a safer tomorrow.

Padlock Clip® Defect Closure System

  • An over-the-scope endoscopic clip designed to encircle, lift, close, and heal tissue defects
  • Easy and intuitive assembly with deployment wire running outside the scope
  • Provides an open and free instrument channel for optimal endoscope suction and utilization of through-the-scope devices

REQUEST A QUOTE

Shop Now

Product Overview

Instrument Cleaning Chemistries for Manual Cleaning at the Sink
Padlock Clip system deployed in felt

The Padlock Clip defect closure system is an endoscopic clip that facilitates full circumferential tissue closure. The over-the-scope Padlock Clip system consists of a pre-loaded, self-grasping hemostatic clip designed to encircle, lift, close, and potentiate the healing of tissue defects.

How the Padlock Clip Defect Closure System Works

The Padlock Clip system is indicated for clip placement within the gastrointestinal (GI) tract for endoscopic marking of lesions, endoscopic clip closure of GI tract luminal perforations <20mm that can be treated conservatively, and endoscopic hemostasis for mucosal/ submucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm in diameter, or diverticula in the colon.

The Padlock Clip system features one endoscopic clip that works by lifting and compressing tissue to provide defect closure:

The Padlock Clip system lifting and compressing tissue from a target lesion to provide defect closure.

In 2010, the Padlock Clip system was initially investigated for closure of gastrotomies for natural orifice surgery (NOTES) procedures. Since then, this over-the-scope endoscopic clipping device has been successfully used to treat various conditions. Example applications include:

  • GI Bleeds: Rectal ulcers, polypectomy, and endoscopic mucosal resection (EMR) sites, post-band ulcerations, angiodysplasias, duodenal ulcers, gastric ulcers, and rebleeding ulcers
  • Fistulas: Enterocutaneous fistulas, rectovesical fistulas, rectocutaneous fistulas, gastrocutaneous fistulas following PEG tube removal, and tracheoesophageal fistulas
  • latrogenic Perforations: Duodenal perforation following biliary stent migration, diverticular perforation during screening colonoscopy
  • Anastomotic Leaks: Includes leaks following anterior resection, total colectomy, sigmoid colectomy, and bariatric surgery
  • Tissue Defects: Includes defects following endoscopic resection such as polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), per oral endoscopic myotomy (POEM)

Please reference the videos tab for more information on how to set up the Padlock Clip system or to view the gastrointestinal clip device in use during multiple clinical situations.

Why the Padlock Clip Defect Closure System?

The over-the-scope Padlock Clip system...

  • Features an over-the-scope endoscopic clip designed to encircle, lift, close, and heal tissue defects
  • Easy and intuitive assembly with deployment wire running outside the scope
  • Provides an open and free instrument channel for optimal endoscope suction and utilization of through-the-scope devices
  • Deploys via a "push of the thumb" one-hand actuation
  • Lays flat against the tissue once deployed
  • Compatible with an Overtube to assist with intubation

Clinical information supporting the Padlock Clip system

Since 2010, the Padlock Clip system has been studied extensively in pre-clinical and clinical studies. The conclusions of several significant studies are highlighted below:

  • In 2015, Armenllini et al. studied five patients treated with the Padlock Clip system and concluded, “The new over-the-scope Padlock Clip™ [system] seems to be simple to use and effective in different clinical settings, particularly in “difficult” scenarios, like recurrent bleeding and respiratory-esophageal fistulas”1
  • In 2017, Dinelli et al. studied 14 patients treated with the Padlock Clip system and concluded, “The novel Padlock Clip seems to be an effective and safe tool to treat gastrointestinal fistulas, perforations or post-polypectomy bleeding”2
  • In 2017, Vare et al. studied 19 patients treated with the Padlock Clip system and concluded, “The new OTS Clip [Padlock Clip system] is safe and effective for the treatment of severe bleeding, for closure of post ER [endoscopic resection] full-thickness defects and closure of chronic fistulae”3
  • In 2019, Goenka et al. studied seven patients treated with the Padlock Clip system and concluded, “The Padlock clip is a novel OTSC, with benefits that include safe, simple, and rapid deployment. Antiplatelet therapy may be reinstated for patients, when necessary, shortly after applying the Padlock clip due to full-thickness closure of the tissue”4
 

REQUEST A QUOTE

 

1 https://www.wjgnet.com/1007-9327/full/v21/i48/13587.htm

2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5396862/

3 https://onlinelibrary.wiley.com/doi/10.1111/jgh.13881

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900306/

 

Go to Top of Page
 

Videos

The following videos may contain images from medical procedures. Due to this content, the video is age-restricted by YouTube and cannot be viewed directly on this page. In order to view select videos, please visit the STERIS Endoscopy YouTube channel and sign into your YouTube account.

Endoscopic Defect Closure:
Clinical Scenarios &
Technical Tips

Padlock Clip® defect closure system - closure of a
tracheoesophageal fistula

Padlock Clip® defect closure system – closure of a
iatrogenic duodenal perforation

Padlock Clip® defect closure system – closure of an enterocutaneous fistula

Padlock Clip® defect closure system – closure of a gastrocutaneous fistula

Padlock Clip® defect closure system – closure of colonoscopic perforation

Padlock Clip® defect closure system - endoscopic closure of an
esophageal perforation

Padlock Clip® defect
closure system -
mounting and deployment

Padlock Clip® defect
closure system -
colon closure

Padlock Clip® defect closure system - gastric closure

Go to Top of Page
 

FAQs

What is an endoscopic clip?

Endoscopic clips, also commonly referred to as hemostatic or colonoscopy clips, are suitable for various clinical applications and widely used in GI endoscopy to treat bleeds and tissue defects. A tissue defect is a broad term for perforations, anastomotic leaks, ulcers, fistulas, and resection sites.

How do you use an endoscopic clip?

Endoscopic clips provide closure by mechanically compressing tissue. The Padlock Clip defect closure system provides full circumferential approximation by encircling the defect, folding, and shortening the gathered tissue towards its center.

Before deployment, the endoscopic clip is positioned within the delivery system housing mechanism referred to as a tissue chamber. The tissue chamber draws targeted tissue into an ideal position for endoscopic clip placement.

As deployment is initiated, the clip prongs pierce the target tissue in a circle around the defect, holding it securely. During this piercing, tissue controllers on the prongs limit penetration depth. As the clip clears the delivery system housing, the prongs pull inwards towards each other as they radially compress the secured tissue towards its center. The tissue controllers and gaps between the prongs moderate tissue-on-tissue pressure while effectively closing the defect.

Padlock Clip Pro-Select Defect Closure System
Padlock Clip Pro-Select
Defect Closure System

How big is a hemostatic clip?

Hemostatic clips range in size. The Padlock Clip defect closure system is offered in two forms: the Padlock Clip defect closure system and the Padlock Clip Pro Select® defect closure system. The Padlock Clip system is for endoscopes with tip diameters ranging from 9.5mm to 11mm. The Padlock Clip Pro-Select system is for endoscopes with tip diameters ranging from 11.3mm to 14mm. Once deployed, the Padlock Clip measures 19mm from end to end.

How long do endoscopic clips stay in?

How long an endoscopic clip is retained depends on the amount of tissue captured (mucosal vs. submucosal vs. full thickness), native tissue response, and patient medical history. The Padlock Clip system may pass naturally after the defect has healed. Documented Padlock Clip system retention has ranged from one month to two years after placement.5 Through-the-scope clips are also designed to remain in patients long enough to allow healing, but anecdotal reports show some have remained in patients for years.

Do endoclips need to be removed?

While physicians have used many techniques with varying degrees of success, endoclips are not intended to be removed once placed. The same is true for through-the-scope clips and over-the-scope clips. One experiment in an animal model reported removing the Padlock Clip system with a snare.6

Are endoclips MRI conditional?

The Padlock Clip system is labeled MR conditional – a patient can be safely scanned in an MR system with a static magnetic field of 1.5. and 3 Tesla*

A patient with this device can be safely scanned in an MR system meeting the following conditions. Failure to follow these conditions may result in injury to the patient.

Non-clinical testing has demonstrated the Padlock Clip® defect closure system and Padlock Clip Pro-Select® defect closure system implants are MR Conditional

Name/Identification of device

Padlock Clip® defect closure system
Padlock Clip Pro-Select® defect closure system

Nominal value(s) of Static Magnetic Field [T]

1.5T and 3.0T

Maximum Spatial Field Gradient [T/m and gauss/cm]

19T/m (1900 gauss/cm)

Maximum MR System Whole-Body averaged specific absorption rate (SAR) [W/kg]

2.0 W/kg

Limits on Scan Duration

Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 3°C after 15 minutes of continuous scanning.

MR Image Artifact

In non-clinical testing, the image artifact caused by the device extends radially up to 0.6cm and 0.9cm (respectively) from the device when imaged with a gradient of echo pulse sequence in a 1.5T MR system and a gradient echo pulse sequence in a 3.0T MR system

 

WARNINGS AND PRECAUTIONS:

Precaution: It is recommended that healthcare providers distribute Patient Implant Cards with the name of the clip and date it was placed.

Warning: Failure to follow the recommended MR Conditional labeling may result in a deployed GI hemoclip dislodging from tissue or heating of tissue at the GI hemoclip location. A GI hemoclip dislodgement may result in rebleeding requiring additional intervention or surgery, serious injury, or death.

 

5 https://www.wjgnet.com/1007-9327/full/v21/i48/13587.htm https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707885/

6https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0030-1255620

 

 
Go to Top of Page
 

Shop Now

Browse a complete Item Number list and easily reorder Padlock Clip® Defect Closure System products on Shop STERIS.

Product Number Description Length Endoscope Distal Tip Diameter Tissue Chamber Depth Tissue Chamber Inner Diameter Housing Outer Diameter Unit/Box


C910001 Padlock Clip® Defect Closure System 177cm 9.5-11mm 10mm 11mm 16mm 1
C913131 Padlock Clip Pro-Select® Defect Closure System 177cm 11.3, 12.0, 12.5, 13.0, 13.5, 14.0mm 4, 8, 11, 13, 15, 19mm 11mm 19mm 1

 

Go to Top of Page
 

Literature

INSTRUCTIONS FOR USE
Document # Document Title
PADLOCK CLIP IFU
BROCHURE
Document # Document Title
2022 NEW & FEATURED BROCHURE - US
NEW & FEATURED BROCHURE INTL 2022
ADVANCED POLYPECTOMY AND ELECTROSURGERY BROCHURE
HEMOSTASIS BROCHURE
HEMOSTASIS INTL BROCHURE
SELL SHEET
Document # Document Title
HEMOSTASIS CHECKLIST
PADLOCK CLIP US SS
PADLOCK CLIP INTL SS
BLEED BOX US SPEC SHEET
QUICK START GUIDE
Document # Document Title
PADLOCK CLIP QRG
ARTICLE ABSTRACT
Document # Document Title
PADLOCK CLIP ARTICLE ABSTRACT - GASTROTOMY CLOSURE WITH THE LOCK-IT SYSTEM AND THE PADLOCK-G CLIP
PADLOCK ARTICLE ABSTRACT - NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY
PADLOCK ARTICLE ABSTRACT - NOVEL ENDOSCOPIC OVER-THE-SCOPE CLIP SYSTEM
PADLOCK ARTICLE ABSTRACT - SUCCESSFUL ENDOSCOPIC CLOSURE OF IATROGENIC DUODENAL PERFORATION
PADLOCK ARTICLE ABSTRACT - YES, WE CAN: RELIABLE COLONIC CLOSURE WITH THE PADLOCK
PALDOCK ARTICLE ABSTRACT - ENDOSCOPIC CLOSURE OF A REFRACTORY GASTROCUTANEOUS FISTULA
PADLOCK ARTICLE ABSTRACT - ENDOSCOPIC CLOSURE OF ANTERIOR RESECTION ANASTOMOTIC DEHISCENCE
PADLOCK ARTICLE ABSTRACT - SUCCESSFUL ENDOSCOPIC CLOSURE OF A GASTROCUTANEOUS FISTULA
PADLOCK ARTICLE ABSTRACT - ENDOSCOPIC CLOSURE OF A PERSISTENT ANASTOMOTIC LEAK
PADLOCK ARTICLE ABSTRACT - A NOVEL ENDOSCOPIC TREATMENT FOR ANASTOMOTIC LEAKAGE POST ANTERIOR RESECTION
PADLOCK ARTICLE ABSTRACT - A NOVEL METHOD FOR CLOSURE OF A PERSISTENT GASTROSTOMY FEEDING SITE
PADLOCK ARTICLE ABSTRACT - FIRST CLINICAL EXPERIENCES WITH A NOVEL ENDOSCOPIC OVER-THE-SCOPE CLIP
CASE STUDY
Document # Document Title
PADLOCK CLIP CASE REPORT - CLOSURE OF A LARGE GASTRIC ULCER
PADLOCK CLIP CASE REPORT - ENDOSCOPIC CLOSURE OF AN ACCIDENTAL ESOPHAGEAL PERFORATION
PADLOCK CLIP CASE REPORT - ENDOSCOPIC CLOSURE OF AN ANASTOMOTIC LEAK
PADLOCK CASE SERIES - DR. HODGDON
PADLOCK CASE REPORT - DR. DIEHL - COLON PERFORATION CLOSURE
PADLOCK CASE REPORT - DR. TZIMAS - ENDOSCOPIC MANAGEMENT OF POST-BAND ULCERATION
PADLOCK CASE REPORT - DR. DIEHL - ENDOSCOPIC CLOSURE OF A BLEEDING POLYPECTOMY SITE
PADLOCK CASE REPORT - TREATMENT OF DUODENAL ULCER - DR SACHDEV
PADLOCK DR. ZULLI CASE REPORT - ENDOSCOPIC CLOSURE OF AN ACTIVELY BLEEDING DUODENAL ULCER
Go to Top of Page
 

 

The product descriptions and information appearing on this webpage (and the associated web links) are for informational purposes and relate solely to Padlock Clip Defect Closure Systems advertised and sold in the US and International markets outside of Germany. For descriptions and information relating to STERIS Endoscopy products advertised and sold in Germany, see https://www.steris.com/healthcare/products/endoscopy-devices/german.

Go to Top of Page