Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip

Study Overview
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Brief Summary
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This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.

Detailed Description
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Endoscopic clipping devices are instruments designed to achieve tissue approximation during gastrointestinal endoscopy. Although endoscopic clips were initially developed for the primary purposes of accomplishing hemostasis of focal gastrointestinal bleeding, the indications for endoscopic clipping have expanded to include closure of perforations and fistulas, securing positioning of catheters and stents as well as to provide a radio-opaque markers to direct endoscopic, radiological, and surgical therapy. Traditionally, through-the-scope (TTS) clipping devices consist of 2 main components: metallic double pronged clips and delivery/deployment catheter-handle assembly. TTS clips are the most used devices for both hemostasis and defect closure given the familiarity and ease of use. However, larger defects or those in a difficult position within the GI tract can be difficult to close using conventional TTS clips alone, given the inherent restrictions in clip opening width and inability to approximate large gaps firmly and securely. Incomplete closure can have serious consequences, including delayed bleeding and need for additional interventions including surgery for treatment of acute perforations. The Dual Action Tissue (DAT) clip is a novel, Federal Drug and Administration (FDA) approved commercially available 3-arm TTS clip designed for endoscopic closure of large defects. Compared to conventional TTS clips, the DAT clip has an additional center post or fixed column in the middle position. The two arms of the DAT clip operate independent of each other, with an overall maximum opening width angle of 60 degrees. Opening and closing of each arm is controlled by two color-coded handles, which facilitates distinguishment of the clip arms during operation. The arm on one side of the DAT clip is opened to clamp the edge of a defect. The clamped mucosa can then be pulled close to the other side of the defect. The second arm of the DAT is then opened to clamp the opposite edge. Once both edges of the defect are secured by the arms of the DAT clip, the clip can then be deployed by firmly pressing and releasing both handles simultaneously. Experimental studies using the DAT clip have confirmed its safety and efficacy and shown it to be easy to operate, safe and effective for defect closure. Our initial experience in 6 cases (unpublished data) supports its safety and its utility as an additional endoscopic tool in our armamentarium for challenging tissue approximation. However, more data is needed to evaluate the performance and the role of the DAT clip. The purpose of this study is to prospectively evaluate our experience with the DAT clip as part of routine medical care.

Official Title
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Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip

Conditions
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GI Bleeding, Perforation Colon, Perforation Bowel, Perforation Duodenal, Perforated Bowel, Fistula

Intervention / Treatment
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* Device: DAT Clip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older. Patients scheduled to undergo endoscopic procedures as part of their routine care in which endoscopic clip closure is clinically indicated: Treatment of bleeding Treatment of perforation and/or fistulas Tissue approximation for mucosal gaps associated with endoscopic resection (e.g., endoscopic mucosal resection, endoscopic submucosal dissection) or third space endoscopy (e.g., peroral endoscopic myotomy in the gastrointestinal tract) Exclusion Criteria: Any contraindications to performing endoscopy. Participants in another research protocol that could interfere or influence the outcomes measures of the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DAT Clip|All patients scheduled to undergo endoscopic procedures as medically indicated will be considered for the study. Data will be prospectively recorded according to the data collection form. The use of the DAT clip will be performed as medically indicated and consistent with the indications for endoscopic clipping (e.g., management of bleeding, treatment of fistulas, perforations, tissue approximation). The investigators on this project will also oversee the medical care of all patients that will participate in the study. Therefore, follow-up will be carried out as medically indicated and no clinical visits will be needed specifically for the purpose of this study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete closure rate. | Cases in which complete tissue approximation is achieved with the use of the DAT clip- no substantial gaps are visible in the closure line. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Achievement of intended targeted therapy. | Defined as cases in which utilization of the DAT clip accomplished the intended treatment effect (e.g., hemostasis, perforation closure) | 12 months | 
| Procedural time. | Measure of procedural time associated with the operation of the DAT clip for its intended purpose. | 12 months | 
| Adverse Events | Measured based on the rate of adverse events with the procedure. | 12 months |