Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition



Sponsors


Source

University of Colorado, Denver

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2016-12-12

Completion Date

2022-12-16

Primary Completion Date

2020-12-16

Study Type

Observational [Patient Registry]

Primary Outcome

Measure

Time Frame

Technical and clinical success in endoscopic tissue apposition
From baseline to one year
Adverse Events
From baseline to one year

Enrollment

500

Conditions


Eligibility

Study Pop

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

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

Gender

All

Minimum Age

18 Years

Maximum Age

89 Years


Overall Contact

Last Name

Abigail Lowe

Phone

303-724-6070

Email



Location

Facility

Status

Contact

Investigator

University of Colorado Hospital
Aurora Colorado 80045 United States
Recruiting
Last Name: Abigail Lowe
Phone: 303-724-6070
Email: [email protected]
Last Name: Mihir Wagh, MD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Firstreceived Results Date

N/A

Target Duration

2 Years

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Other

Time Perspective

Prospective


Study First Submitted

August 2, 2018

Study First Submitted Qc

August 7, 2018

Study First Posted

August 10, 2018

Last Update Submitted

August 7, 2018

Last Update Submitted Qc

August 7, 2018

Last Update Posted

August 10, 2018


ClinicalTrials.gov processed this data on August 10, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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