Endoscopic Treatment of Intestinal Fistulas and Perforations

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01303653

Enrollment

Registered

2011-02-25

Start date

2010-10-31

Completion date

Unknown

Last updated

2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Fistula, Gastrointestinal Perforation

Keywords

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

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.

Interventions

PROCEDUREendoscopic closure of gastrointestinal fistulas and perforations

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events as a measure of safety and tolerability	6 months	elective endoscopy to evaluate tissue closure

Countries

United States

Contacts

Primary ContactLee L Swanstrom, MD

lswanstrom@aol.com503 281 0561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026