Padlock Clip^® Defect Closure System

Product Overview

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:

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

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/

 

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.

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

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*

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