Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852457
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-05-02
Brief Title:
Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue DAT Clip
Sponsor:
AdventHealth
Organization:
AdventHealth
Study Overview
Official Title:
Prospective Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue DAT Clip
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 deliverydeployment 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
Traditionally through-the-scope TTS clipping devices consist of 2 main components metallic double pronged clips and deliverydeployment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None