search
Back to results

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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intraband pressure recording system
Conventional Adjustment
Sponsored by
Ethicon Endo-Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid Obesity, Gastric Banding, Bariatric Banding, Swedish Adjustable Gastric Band

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adelaide Bariatric Center
  • OB Klinika, a.s.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Adjustment Group

Intraband Pressure Arm

Arm 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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
August 14, 2009
Last Updated
August 14, 2012
Sponsor
Ethicon Endo-Surgery
search

1. Study Identification

Unique Protocol Identification Number
NCT00960843
Brief Title
Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid Obesity, Gastric Banding, Bariatric Banding, Swedish Adjustable Gastric Band

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Adjustment Group
Arm Type
Active Comparator
Arm Description
Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Arm Title
Intraband Pressure Arm
Arm Type
Active Comparator
Arm Description
Subjects whose band adjustments will be guided by intraband pressure readings.
Intervention Type
Device
Intervention Name(s)
Intraband pressure recording system
Intervention Description
Intraband pressure will be measured by a pressure recording system.
Intervention Type
Other
Intervention Name(s)
Conventional Adjustment
Intervention Description
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Primary Outcome Measure Information:
Title
Percent Excess Weight Change at Day 180
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
Secondary Outcome Measure Information:
Title
Mean Static Intraband Pressure at Day 180
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
Title
Rate of Weight Loss kg/wk at Day 180
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Adelaide Bariatric Center
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
OB Klinika, a.s.
City
Prague
Country
Czech Republic

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs