Trial Outcomes & Findings for Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety (NCT NCT00960843)

Last Updated: 2012-08-20

Results Overview

Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Screening to Day 180

Results posted on

2012-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional Adjustment Group Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).	Intraband Pressure Arm Subjects whose band adjustments will be guided by intraband pressure readings.
Overall Study STARTED	25	26
Overall Study COMPLETED	23	21
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional Adjustment Group Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).	Intraband Pressure Arm Subjects whose band adjustments will be guided by intraband pressure readings.
Overall Study Lost to Follow-up	2	0
Overall Study Protocol Violation	0	4
Overall Study Repeated needle dislodgment	0	1

Baseline Characteristics

Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Adjustment Group n=25 Participants Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).	Intraband Pressure Arm n=26 Participants Subjects whose band adjustments will be guided by intraband pressure readings.	Total n=51 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	24 Participants n=93 Participants	25 Participants n=4 Participants	49 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age Continuous	47.2 years STANDARD_DEVIATION 11.93 • n=93 Participants	45.1 years STANDARD_DEVIATION 12.69 • n=4 Participants	46.1 years STANDARD_DEVIATION 12.25 • n=27 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment Czech Republic	12 participants n=93 Participants	12 participants n=4 Participants	24 participants n=27 Participants
Region of Enrollment Australia	13 participants n=93 Participants	14 participants n=4 Participants	27 participants n=27 Participants

PRIMARY outcome

Timeframe: Screening to Day 180

Population: Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.

Outcome measures

Outcome measures
Measure	Conventional Arm n=10 Participants Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band	Intraband Pressure Arm n=11 Participants Pressure adjustments based on protocol instructions regarding intraband pressure measurements
Percent Excess Weight Change at Day 180	-13.2 percentage of excess weight at screening Standard Deviation 11.1	-24.2 percentage of excess weight at screening Standard Deviation 17.5

SECONDARY outcome

Timeframe: Day 180

Population: Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis.

Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)

Outcome measures

Outcome measures
Measure	Conventional Arm n=10 Participants Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band	Intraband Pressure Arm n=10 Participants Pressure adjustments based on protocol instructions regarding intraband pressure measurements
Mean Static Intraband Pressure at Day 180	0.7 mmHg Standard Deviation 7.03	15.8 mmHg Standard Deviation 17.82

SECONDARY outcome

Timeframe: Screening to Day 180

Population: Per Protocol population

Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).

Outcome measures

Outcome measures
Measure	Conventional Arm n=10 Participants Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band	Intraband Pressure Arm n=11 Participants Pressure adjustments based on protocol instructions regarding intraband pressure measurements
Rate of Weight Loss kg/wk at Day 180	0.18 kg/week Standard Deviation 0.10	0.43 kg/week Standard Deviation 0.32

Adverse Events

Conventional Adjustment Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Intraband Pressure Arm

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Conventional Adjustment Group n=25 participants at risk Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).	Intraband Pressure Arm n=26 participants at risk Subjects whose band adjustments will be guided by intraband pressure readings.
Injury, poisoning and procedural complications Medical device complication	0.00% 0/25	3.8% 1/26 • Number of events 1

Other adverse events

Other adverse events
Measure	Conventional Adjustment Group n=25 participants at risk Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).	Intraband Pressure Arm n=26 participants at risk Subjects whose band adjustments will be guided by intraband pressure readings.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/25	3.8% 1/26 • Number of events 1
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 1	0.00% 0/26
Gastrointestinal disorders Epigastric discomfort	8.0% 2/25 • Number of events 2	11.5% 3/26 • Number of events 5
Gastrointestinal disorders Gastrooesophageal reflux disease	4.0% 1/25 • Number of events 1	7.7% 2/26 • Number of events 4
Gastrointestinal disorders Oesophageal obstruction	4.0% 1/25 • Number of events 1	0.00% 0/26
Gastrointestinal disorders Regurgitation	4.0% 1/25 • Number of events 1	0.00% 0/26
Gastrointestinal disorders Vomiting	12.0% 3/25 • Number of events 4	38.5% 10/26 • Number of events 13
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.0% 1/25 • Number of events 1	0.00% 0/26
Nervous system disorders Headache	0.00% 0/25	3.8% 1/26 • Number of events 1

Additional Information

Michael Schwiers Principal Biostatistician

Ethicon Endo-Surgery Inc.

Phone: 513-337-1172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60