Trial Outcomes & Findings for Safety and Efficacy Study of Duet TRS (NCT NCT00950872)

NCT ID: NCT00950872

Last Updated: 2014-05-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: Day 30
• Results posted on: 2014-05-01

Participant Flow

Between November 24, 2009 and March 29, 2010, a total of 29 patients were consented and screened for potential study participation at one institution (Duke University). Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Subjects were evaluated for pre-operative and intra-operative eligibility criteria prior to enrollment.

Participant milestones

Measure	Duet TRS Duet TRS is a staple line buttress
Overall Study STARTED	29
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Duet TRS Duet TRS is a staple line buttress
Overall Study Withdrawal by Subject	1
Overall Study Did not have surgery	2

Baseline Characteristics

Safety and Efficacy Study of Duet TRS

Baseline characteristics by cohort

Measure	Duet TRS n=29 Participants Subjects receive Duet TRS Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
Age, Continuous	42.2 years STANDARD_DEVIATION 11.3 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Outcome measures

Measure	Duet TRS n=27 Participants Duet TRS is a staple line buttress
Incidence of Adverse Events.	6 adverse events

SECONDARY outcome

Timeframe: Day 0

Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.

Outcome measures

Measure	Duet TRS n=27 Participants Duet TRS is a staple line buttress
Operating Room (OR) Time	98 minutes Standard Deviation 27 • Interval 62.0 to 165.0

SECONDARY outcome

Timeframe: Day 2 (Approximately 1.5 days post randomization)

Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Days spent in the hospital

Outcome measures

Measure	Duet TRS n=27 Participants Duet TRS is a staple line buttress
Length of Hospital Stay	1.5 days Standard Deviation 0.6 • Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Day 0

Population: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.

Outcome measures

Measure	Duet TRS n=27 Participants Duet TRS is a staple line buttress
Incidence of Stapler 'Misfires'	3 participants

Adverse Events

Duet TRS

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Duet TRS n=27 participants at risk Duet TRS is a staple line buttress
Gastrointestinal disorders Gastrojejunal Anatomosis Stricture	7.4% 2/27 • Number of events 2 • 1 month

Other adverse events

Adverse event data not reported

Additional Information

Noreen Fahey, Director, Clinical Program Management

Covidien

Phone: 203-821-4716

Email: noreen.fahey@covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place