Trial Outcomes & Findings for A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty (NCT NCT00684749)

NCT ID: NCT00684749

Last Updated: 2015-02-23

Results Overview

Surgeon completed survey

• Recruitment status: COMPLETED
• Target enrollment: 142 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2015-02-23

Participant Flow

Surgeons recruited their own patients in their own offices

as above.

Participant milestones

Measure	Total Population All surgical patients
Overall Study STARTED	142
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty

Baseline characteristics by cohort

Measure	Total Population n=142 Participants All surgical patients
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	142 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All patients who were treated in the time period

Surgeon completed survey

Outcome measures

Measure	Total Population n=142 Participants All surgical patients
Reoperation Rates	6 participants

SECONDARY outcome

Timeframe: 1 Year

Patient completed a survey regarding outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year

Patient completedsurvey regarding outcome

Outcome measures

Outcome data not reported

Adverse Events

Total Population

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

Umar Choudry/Bruce Cunningham

University of Minnesota

Phone: 6126250697

Email: choud008@umn.edu

Results disclosure agreements

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