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

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ClinicalTrials.gov Identifier: NCT00960843
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : April 3, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Morbid Obesity
Interventions Device: Intraband pressure recording system
Other: Conventional Adjustment
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conventional Adjustment Group Intraband Pressure Arm
Hide Arm/Group Description Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). Subjects whose band adjustments will be guided by intraband pressure readings.
Period Title: Overall Study
Started 25 26
Completed 23 21
Not Completed 2 5
Reason Not Completed
Lost to Follow-up             2             0
Protocol Violation             0             4
Repeated needle dislodgment             0             1
Arm/Group Title Conventional Adjustment Group Intraband Pressure Arm Total
Hide Arm/Group Description Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). Subjects whose band adjustments will be guided by intraband pressure readings. Total of all reporting groups
Overall Number of Baseline Participants 25 26 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  96.0%
25
  96.2%
49
  96.1%
>=65 years
1
   4.0%
1
   3.8%
2
   3.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 26 participants 51 participants
47.2  (11.93) 45.1  (12.69) 46.1  (12.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
Female
21
  84.0%
21
  80.8%
42
  82.4%
Male
4
  16.0%
5
  19.2%
9
  17.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
Czech Republic 12 12 24
Australia 13 14 27
1.Primary Outcome
Title Percent Excess Weight Change at Day 180
Hide Description 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.
Time Frame Screening to Day 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.
Arm/Group Title Conventional Arm Intraband Pressure Arm
Hide Arm/Group Description:
Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
Pressure adjustments based on protocol instructions regarding intraband pressure measurements
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: percentage of excess weight at screening
-13.2  (11.1) -24.2  (17.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Arm, Intraband Pressure Arm
Comments Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0520
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Static Intraband Pressure at Day 180
Hide Description 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)
Time Frame Day 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Conventional Arm Intraband Pressure Arm
Hide Arm/Group Description:
Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
Pressure adjustments based on protocol instructions regarding intraband pressure measurements
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
0.7  (7.03) 15.8  (17.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Arm, Intraband Pressure Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0225
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Rate of Weight Loss kg/wk at Day 180
Hide Description Rate of weight loss = (screening weight (kg) – weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).
Time Frame Screening to Day 180
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population
Arm/Group Title Conventional Arm Intraband Pressure Arm
Hide Arm/Group Description:
Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
Pressure adjustments based on protocol instructions regarding intraband pressure measurements
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: kg/week
0.18  (0.10) 0.43  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Arm, Intraband Pressure Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0193
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Adjustment Group Intraband Pressure Arm
Hide Arm/Group Description Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). Subjects whose band adjustments will be guided by intraband pressure readings.
All-Cause Mortality
Conventional Adjustment Group Intraband Pressure Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Adjustment Group Intraband Pressure Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      1/26 (3.85%)    
Injury, poisoning and procedural complications     
Medical device complication  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Conventional Adjustment Group Intraband Pressure Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/25 (24.00%)      11/26 (42.31%)    
Gastrointestinal disorders     
Abdominal discomfort  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Abdominal pain  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Epigastric discomfort  1  2/25 (8.00%)  2 3/26 (11.54%)  5
Gastrooesophageal reflux disease  1  1/25 (4.00%)  1 2/26 (7.69%)  4
Oesophageal obstruction  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Regurgitation  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Vomiting  1  3/25 (12.00%)  4 10/26 (38.46%)  13
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1  1/25 (4.00%)  1 0/26 (0.00%)  0
Nervous system disorders     
Headache  1  0/25 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Schwiers Principal Biostatistician
Organization: Ethicon Endo-Surgery Inc.
Phone: 513-337-1172
Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00960843     History of Changes
Other Study ID Numbers: CI-08-0009
First Submitted: August 14, 2009
First Posted: August 18, 2009
Results First Submitted: November 2, 2011
Results First Posted: April 3, 2012
Last Update Posted: August 20, 2012