Trial Outcomes & Findings for Efficacy Study to Evaluate Laparoscopic Fascial Closure Device (NCT NCT01024296)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Day 1, at the end of surgery

Results posted on

2017-10-12

Participant milestones
Measure	Gastric Bypass Surgery Patients Port Close: Device for applying loop suture to close surgical site
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Efficacy Study to Evaluate Laparoscopic Fascial Closure Device

Baseline characteristics by cohort
Measure	Gastric Bypass Surgery Patients n=4 Participants Port Close: Device for applying loop suture to close surgical site
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

Timeframe: Day 1, at the end of surgery

Outcome measures
Measure	Gastric Bypass Surgery Patients n=4 Participants Port Close: Device for applying loop suture to close surgical site
Count of Participants With Successful Port Site Closure Using Port Close Device	3 Participants

Timeframe: Day 1, from insertion to removal of Port Close device during surgery

Population: Participants with successful closure using the Port Close device were included in the analysis.

Outcome measures
Measure	Gastric Bypass Surgery Patients n=3 Participants Port Close: Device for applying loop suture to close surgical site
Time of Port Site Closure	138.7 seconds Standard Deviation 22.21

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Stanford University

Phone: (215) 738-0400