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

NCT00960843 | Completed Results

• 1 other identifier: CI-08-0009
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 2

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.

Conditions

Morbid Obesity

Keywords

Morbid Obesity; Gastric Banding; Bariatric Banding; Swedish Adjustable Gastric Band

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening to Day 180

Secondary Outcomes (2)

• Mean Static Intraband Pressure at Day 180

  Day 180

• Rate of Weight Loss kg/wk at Day 180

  Screening to Day 180

Study Arms (2)

Conventional Adjustment Group

ACTIVE COMPARATOR

Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).

Other: Conventional Adjustment

Intraband Pressure Arm

ACTIVE COMPARATOR

Subjects whose band adjustments will be guided by intraband pressure readings.

Device: Intraband pressure recording system

Interventions

Intraband pressure recording system DEVICE

Intraband pressure will be measured by a pressure recording system.

Intraband Pressure Arm

Conventional Adjustment OTHER

Band adjustments will be made via conventional standard of care (e.g., volume, hunger).

Conventional Adjustment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (2)

Adelaide Bariatric Center

Bedford Park, South Australia, 5042, Australia

Location

OB Klinika, a.s.

Prague, Czechia

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Schwiers Principal Biostatistician
• Organization: Ethicon Endo-Surgery Inc.

mschwier@its.jnj.com

513-337-1172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 18, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 20, 2012
• Results First Posted: April 3, 2012

Record last verified: 2012-08

Locations

AU (1); CZ (1)