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

NCT00960843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2012-08-20

Study results available
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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

Interventions

DEVICE

Intraband pressure recording system

Intraband pressure will be measured by a pressure recording system.

OTHER

Conventional Adjustment

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

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Australia
  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960843 on ClinicalTrials.gov