Trial Outcomes & Findings for LapBand Adjustment to Improve Early Weight Loss (NCT NCT01060592)

NCT ID: NCT01060592

Last Updated: 2013-04-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 35 participants
• Primary outcome timeframe: 4-6 weeks post surgery
• Results posted on: 2013-04-08

Participant Flow

35 pts recruited between Oct 2009 and Jan 2010

N/A - Single arm non-randomized study

Participant milestones

Measure	Stoma Adjustment at Surgery The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery	Historic Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
4-6w STARTED	35	49
4-6w COMPLETED	23	39
4-6w NOT COMPLETED	12	10
12m STARTED	35	49
12m COMPLETED	35	31
12m NOT COMPLETED	0	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LapBand Adjustment to Improve Early Weight Loss

Baseline characteristics by cohort

Measure	Historic n=49 Participants Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records	Stoma Adjustment at Surgery n=35 Participants The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery	Total n=84 Participants Total of all reporting groups
Age Continuous	43.0 years STANDARD_DEVIATION 11.6 • n=5 Participants	40.1 years STANDARD_DEVIATION 11.6 • n=7 Participants	42.8 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	28 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	35 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 weeks post surgery

Outcome measures

Measure	Historic n=39 Participants Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records	Stoma Adjustment at Surgery n=23 Participants The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)	15.63 %EWL Standard Deviation 8.9	20.8 %EWL Standard Deviation 10.8

PRIMARY outcome

Timeframe: 4-6 weeks post surgery

Outcome measures

Measure	Historic n=28 Participants Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records	Stoma Adjustment at Surgery n=16 Participants The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)	16.33 %EWL Standard Deviation 9.54	23.07 %EWL Standard Deviation 11.59

PRIMARY outcome

Timeframe: 12m post surgery

Outcome measures

Measure	Historic n=31 Participants Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records	Stoma Adjustment at Surgery n=35 Participants The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)	48.3 %EWL Standard Deviation 15	50.4 %EWL Standard Deviation 24.5

PRIMARY outcome

Timeframe: 12m post surgery

Outcome measures

Measure	Historic n=26 Participants Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records	Stoma Adjustment at Surgery n=23 Participants The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)	48.71 %EWL Standard Deviation 15.61	60.32 %EWL Standard Deviation 22.77

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Historic n=49 Participants Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records	Stoma Adjustment at Surgery n=35 Participants The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
Number of Band Adjustments Required in the First Year After Surgery	6.47 Number of Adjustments Standard Deviation 3.15	6.66 Number of Adjustments Standard Deviation 2.9

Adverse Events

Historic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stoma Adjustment at Surgery

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

John O'Dea PhD

Crospon

Phone: +353-91-519880

Email: jodea@crospon.com

Results disclosure agreements

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