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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00960843
First received: August 14, 2009
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.


Condition Intervention
Morbid Obesity
Device: Intraband pressure recording system
Other: Conventional Adjustment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, 6-month Study to Compare the Effects of Volume- and Pressure-guided Adjustments on Weight Loss and Satiety in Patients Implanted With the Swedish Adjustable Gastric Band

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Percent Excess Weight Change at Day 180 [ Time Frame: Screening to Day 180 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Static Intraband Pressure at Day 180 [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    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)

  • Rate of Weight Loss kg/wk at Day 180 [ Time Frame: Screening to Day 180 ] [ Designated as safety issue: No ]
    Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).


Enrollment: 51
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Adjustment Group
Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Other: Conventional Adjustment
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Active Comparator: Intraband Pressure Arm
Subjects whose band adjustments will be guided by intraband pressure readings.
Device: Intraband pressure recording system
Intraband pressure will be measured by a pressure recording system.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to comprehend, follow and give informed consent.
  • Be at least 18 years of age at time of trial enrollment.
  • Had a pre-implantation BMI between 35 and 55 kg/m2.
  • Have received a SAGB VC implant 1) 30-60 days (and not undergone first band adjustment yet)prior to the date of enrollment.
  • Willingness to be randomized to intraband-based or conventional adjustments
  • Willingness to consent to monthly visits and possible measurements of intraband pressure (requiring access to the injection port).
  • Willingness to undergo up to 7 band adjustments within the 6-month period of the study.
  • Able to sit approximately at a 90 degree-angle, from the floor, for IBP measurements.
  • Willingness to return to office visits around the same time of the first in-study adjustment (plus or minus 2 hours)
  • Willingness to consent to a limited UGI series if the investigator suspects the presence of a band-related complication or if the intraband pressure recordings deviate from expected.
  • Willingness to refrain from taking medications or supplements indicated for or known to induce weight loss.

Exclusion Criteria:

  • Females currently known to be pregnant.
  • Ongoing or unresolved band perforation or band leakage.
  • Ongoing (unresolved) slippage, erosion, or pouch dilation.
  • Documented esophageal dysmotility/dyskinesia.
  • Ongoing (unresolved) port obstruction or tube kinking.
  • Current injection port infection.
  • History of band revision or replacement.
  • Previously documented or ongoing esophageal dilatation.
  • Any condition that, in the opinion of the Investigator, may jeopardize the subject's well-being or the soundness of this study.
  • Current use of medications or supplements indicated for or known to induce weight loss at any point during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960843

Locations
Australia, South Australia
Adelaide Bariatric Center
Bedford Park, South Australia, Australia, 5042
Czech Republic
OB Klinika, a.s.
Prague, Czech Republic
Sponsors and Collaborators
Ethicon Endo-Surgery
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00960843     History of Changes
Other Study ID Numbers: CI-08-0009
Study First Received: August 14, 2009
Results First Received: November 2, 2011
Last Updated: August 14, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Ethicon Endo-Surgery:
Morbid Obesity
Gastric Banding
Bariatric Banding
Swedish Adjustable Gastric Band

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 23, 2014