NCT02315404

Brief Summary

Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel. The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

3.4 years

First QC Date

January 6, 2014

Last Update Submit

June 20, 2018

Conditions

Obscure Gastrointestinal Bleeding

Keywords

Obscure gastrointestinal bleedingOvert gastrointestinal bleedingOccult gastrointestinal bleedingEnteroscopy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).

    Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified. a. Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices)

    1 day

Secondary Outcomes (5)

  • Overall Diagnostic yield of BAE vs. C-BAE

    1 day

  • Therapeutic yield BAE vs. Cap assisted BAE (C-BAE).

    1 day

  • iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al.

    1 day

  • vProcedure related adverse events.

    1 day

  • Recurrence of GI bleeding at 12 months, as evaluated by questionnaire

    12 months

Study Arms (2)

No cap

PLACEBO COMPARATOR

enteroscopy performed without a cap

Procedure: CAP

Enteroscopy with a cap

ACTIVE COMPARATOR

Enteroscopy performed with a CAP fitted to the end of the scope

Procedure: CAP

Interventions

CAPPROCEDURE

CAP fitted to the end of the endoscope

Enteroscopy with a capNo cap

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia.

You may not qualify if:

  • Unable to provide written informed consent.
  • Pregnancy or lactation.
  • Suspected bowel obstruction or GI perforation.
  • Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
  • Uncorrected coagulopathy (platelet count \<50,000, INR\> 2, PTT\> 2x upper limit of normal).
  • Patient undergoing retrograde BAE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

December 11, 2014

Study Start

January 1, 2014

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

June 25, 2018

Record last verified: 2018-06

Locations

US(1)