Trial Outcomes & Findings for The Clinical Utility of Overtube Use at the Time of Endoscopy (NCT NCT00861263)

Results Overview

The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

193 participants

Primary outcome timeframe

up to 6 yrs after after the endoscopy

Results posted on

2014-04-14

Participant Flow

We started this study in June 2007 and ended this study in Oct 2012. We approached any patient who was scheduled in our endoscopy suite for an overtube enteroscopy.

The only significant event was that the subject was scheduled for an enteroscopy in our facility and a overtube was used at the time of endoscopy.

Participant milestones

Participant milestones
Measure	Enteroscopy Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
Overall Study STARTED	193
Overall Study COMPLETED	193
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Clinical Utility of Overtube Use at the Time of Endoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enteroscopy n=193 Participants Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=93 Participants
Age, Categorical >=65 years	99 Participants n=93 Participants
Age, Continuous	62 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	101 Participants n=93 Participants
Sex: Female, Male Male	92 Participants n=93 Participants
Region of Enrollment United States	193 participants n=93 Participants

PRIMARY outcome

Timeframe: up to 6 yrs after after the endoscopy

The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.

Outcome measures

Outcome measures
Measure	Spiral Enteroscopy Subjects n=61 Participants All subjects followed up after spiral enteroscopy
Number of Patients With Persistent or Recurrent Bleeding	16 participants 12.3

Adverse Events

Enteroscopy

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enteroscopy n=193 participants at risk Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
Cardiac disorders Bradycardia	1.0% 2/193 • Number of events 2 • The adverse event data were collected for 6 years.
Cardiac disorders Chest pain	0.52% 1/193 • Number of events 1 • The adverse event data were collected for 6 years.
Vascular disorders Transient Ischemic Attack	0.52% 1/193 • Number of events 1 • The adverse event data were collected for 6 years.
Cardiac disorders Ventrical Tachycardia Arrest	0.52% 1/193 • Number of events 1 • The adverse event data were collected for 6 years.
Gastrointestinal disorders Partial Thickness Mucosal Tear	1.6% 3/193 • Number of events 3 • The adverse event data were collected for 6 years.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Draganov MD

University of FLorida

Phone: 352-273-9472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place