Prospective Evaluation of the Efficacy and Safety of Endo... | NCT03626194

Studies
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

NCT03626194

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

May 21, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Endoscopic Tissue Apposition
Endoscopic Suturing
Endoscopic Clipping
Bariatric Endoscopy
Transoral Outlet Reduction
Endoscopic Sleeve Gastroplasty

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2016Actual

Primary Completion Date

Dec 16, 2025Estimated

Completion Date

Dec 16, 2026Estimated

First Submitted Date

Aug 2, 2018

First Submission Date that Met QC Criteria

Aug 7, 2018

First Posted Date

Aug 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2024

Last Update Posted Date

May 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.

1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.

1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Technical and clinical success in endoscopic tissue apposition	Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed..	From baseline to one year
Adverse Events	Based on ASGE criteria	From baseline to one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients>18 years of age undergoing endoscopy for any of the following indications:

Indications for Tissue Apposition:

Closure of perforations
Closure of full thickness defects created during endoscopic full thickness resection
Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection
Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)
Stent fixation
Closure of fistulas
Natural Orifice Transluminal Endoscopic Surgery defect closures
Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)
Primary endoscopic sleeve gastroplasty

Exclusion Criteria:

Patients unable or unwilling to provide consent
Pregnant patients
Coagulation disorders (INR >1.8, platelet <50,000)
GI Bleeding
Hemodynamic instability
Enrollment in another device or drug study that may confound the results

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

A prospective database/registry of patients undergoing endoscopic tissue apposition will be formed. Women and minorities will be included as they are frequently found to have indications for which endoscopic tissue apposition may be indicated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abigail Lowe	Contact	303-724-6070		ABIGAIL.LOWE@UCDENVER.EDU

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Hospital	Recruiting	Aurora	Colorado	80045	United States