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
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
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
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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