Trial Outcomes & Findings for Balloon Colonoscopy for Incomplete Colonoscopy (NCT NCT00935857)

Results Overview

Number of patients with a complete colonoscopy to the cecum

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Day of Procedure

Results posted on

2014-09-25

Participant Flow

Subject recruitment completed.

Early termination at 30 patients due to clinically significant differences at midpoint of study. Patients in the Standard Colonoscopy group could cross-over to the Balloon Colonoscopy group after 20 minutes of procedure time but they were not included in further analysis after cross-over.

Participant milestones

Participant milestones
Measure	Balloon Colonoscopy Colonoscopy using the single balloon enteroscope system.	Standard Colonoscopy Colonoscopy using a standard adult colonoscope
Overall Study STARTED	14	16
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Balloon Colonoscopy for Incomplete Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Colonoscopy n=14 Participants Colonoscopy using the single balloon enteroscope system.	Standard Colonoscopy n=16 Participants Colonoscopy using a standard adult colonoscope	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 12.5 • n=93 Participants	59.9 years STANDARD_DEVIATION 10.0 • n=4 Participants	59.2 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	12 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	16 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: Day of Procedure

Population: Per Protocol, Terminated at Interim Analysis

Number of patients with a complete colonoscopy to the cecum

Outcome measures

Outcome measures
Measure	Balloon Colonoscopy n=14 Participants Colonoscopy using the single balloon enteroscope system.	Standard Colonoscopy n=16 Participants Colonoscopy using a standard adult colonoscope
Complete Colonoscopy to the Cecum	13 patients	8 patients

SECONDARY outcome

Timeframe: Day of Procedure

Time, in minutes, until reaching cecum in each arm.

Outcome measures

Outcome measures
Measure	Balloon Colonoscopy n=14 Participants Colonoscopy using the single balloon enteroscope system.	Standard Colonoscopy n=16 Participants Colonoscopy using a standard adult colonoscope
Time (Minutes) to Cecum	24 minutes Standard Deviation 15	22 minutes Standard Deviation 18

SECONDARY outcome

Timeframe: 7 days post procedure

Number of patients with any procedural complications as assessed 7 days after procedure.

Outcome measures

Outcome measures
Measure	Balloon Colonoscopy n=14 Participants Colonoscopy using the single balloon enteroscope system.	Standard Colonoscopy n=16 Participants Colonoscopy using a standard adult colonoscope
Procedural Complications	0 participants	0 participants

Adverse Events

Standard Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Balloon Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rajesh N. Keswani

Northwestern University

Phone: 312-695-5620

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place