NCT01303653

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

February 28, 2011

Status Verified

July 1, 2010

Enrollment Period

Same day

First QC Date

February 24, 2011

Last Update Submit

February 25, 2011

Conditions

Gastrointestinal FistulaGastrointestinal Perforation

Keywords

endoscopic tissue closure,gastro-gastric fistulas,gastrointestinal perforations

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    elective endoscopy to evaluate tissue closure

    6 months

Interventions

endoscopic closure of gastrointestinal fistulas and perforationsPROCEDURE

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

Also known as: Either the Tissue Apposition System (Ethicon Endosurgery), or the Overstitch (Apollo Endosurgery), will be used within this study for tissue closure

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital, Legacy Health System

Portland, Oregon, 97210, United States

RECRUITING

MeSH Terms

Conditions

Digestive System Fistula

Condition Hierarchy (Ancestors)

Digestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Lee L Swanstrom, MD

CONTACT

503 281 0561lswanstrom@aol.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2010

Last Updated

February 28, 2011

Record last verified: 2010-07

Locations

US(1)