Recruiting
Phase 1

Endoscopic Tools

Sponsor:

The Oregon Clinic

Code:

NCT01303653

Conditions

Gastrointestinal Fistula

Gastrointestinal Perforation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

endoscopic closure of gastrointestinal fistulas and perforations

Study Details

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.

Conditions

Gastrointestinal Fistula

Gastrointestinal Perforation

Study ID

NCT01303653

Start date

Oct, 2010

Status verified date

Jul, 2010

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

endoscopic closure of gastrointestinal fistulas and perforations

novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations

Primary outcome measure

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lee L Swanstrom, MD

503 281 0561lswanstrom@aol.com

Locations

Good Samaritan Hospital, Legacy Health System

Recruiting

Portland, Oregon, United States, 97210

Contacts

Lee L Swanstrom, MD

503-281-0561lswanstrom@aol.com

More Information

Sponsor

The Oregon Clinic

Last update posted

Feb 28, 2011

Last verified

Jul, 2010

Keywords

  • endoscopic tissue closure,
  • gastro-gastric fistulas,
  • gastrointestinal perforations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Oregon Clinic on 2011-02-28.