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

NCT ID: NCT00960843

Last Updated: 2012-08-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Keywords

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Morbid Obesity Gastric Banding Bariatric Banding Swedish Adjustable Gastric Band

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Adjustment Group

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

Group Type ACTIVE_COMPARATOR

Conventional Adjustment

Intervention Type OTHER

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

Intraband Pressure Arm

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

Group Type ACTIVE_COMPARATOR

Intraband pressure recording system

Intervention Type DEVICE

Intraband pressure will be measured by a pressure recording system.

Interventions

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Intraband pressure recording system

Intraband pressure will be measured by a pressure recording system.

Intervention Type DEVICE

Conventional Adjustment

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adelaide Bariatric Center

Bedford Park, South Australia, Australia

Site Status

OB Klinika, a.s.

Prague, , Czechia

Site Status

Countries

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Australia Czechia

Other Identifiers

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CI-08-0009

Identifier Type: -

Identifier Source: org_study_id