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Endoscopic Treatment of Intestinal Fistulas and Perforations

Primary Purpose

Gastrointestinal Fistula, Gastrointestinal Perforation

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
endoscopic closure of gastrointestinal fistulas and perforations
Sponsored by
The Oregon Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Fistula focused on measuring endoscopic tissue closure,, gastro-gastric fistulas,, gastrointestinal perforations

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gastrointestinal fistula and perforation
  • Ability to undergo general anesthesia
  • Ability to give informed consent

Exclusion Criteria:

  • Contraindicated for esophagogastroduodenoscopy (EGD)
  • Contraindicated for colonoscopy
  • BMI ≥ 40
  • Presence of esophageal stricture
  • Altered gastric anatomy
  • Intraabdominal abscess or severe inflammation

Sites / Locations

  • Good Samaritan Hospital, Legacy Health SystemRecruiting

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability
elective endoscopy to evaluate tissue closure

Secondary Outcome Measures

Full Information

First Posted
February 24, 2011
Last Updated
February 25, 2011
Sponsor
The Oregon Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01303653
Brief Title
Endoscopic Treatment of Intestinal Fistulas and Perforations
Official Title
Endoscopic Treatment of Intestinal Fistulas and Perforations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Oregon Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.
Detailed Description
Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations. Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Fistula, Gastrointestinal Perforation
Keywords
endoscopic tissue closure,, gastro-gastric fistulas,, gastrointestinal perforations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
endoscopic closure of gastrointestinal fistulas and perforations
Other Intervention Name(s)
Either the Tissue Apposition System (Ethicon Endosurgery), or the Overstitch (Apollo Endosurgery), will be used within this study for tissue closure
Intervention Description
novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
elective endoscopy to evaluate tissue closure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gastrointestinal fistula and perforation Ability to undergo general anesthesia Ability to give informed consent Exclusion Criteria: Contraindicated for esophagogastroduodenoscopy (EGD) Contraindicated for colonoscopy BMI ≥ 40 Presence of esophageal stricture Altered gastric anatomy Intraabdominal abscess or severe inflammation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee L Swanstrom, MD
Phone
503 281 0561
Email
lswanstrom@aol.com
Facility Information:
Facility Name
Good Samaritan Hospital, Legacy Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee L Swanstrom, MD
Phone
503-281-0561
Email
lswanstrom@aol.com
First Name & Middle Initial & Last Name & Degree
Erwin Rieder, MD
First Name & Middle Initial & Last Name & Degree
Angi Gill, RN

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Treatment of Intestinal Fistulas and Perforations

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