Obesity Trial, Completed NCT00960843 Sponsor: Ethicon Endo-Surgery Condition: Obesity
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 25 in the "Conventional Adjustment" group and 26 in the "Intraband Pressure" group. The trial was looking at two different approaches to adjusting a gastric band (a device placed around the stomach as part of a weight-loss procedure), and it followed participants for 180 days (about six months). The main thing being measured was how much of their excess body weight participants lost over that period. By the end of the study, 23 people in the conventional group and 21 in the intraband pressure group had completed the trial. The reported data shows that, for the primary measure — the percentage of excess weight lost over six months — the conventional adjustment group lost an average of 13.2% of their excess weight, while the intraband pressure group lost an average of 24.2% of their excess weight. For one of the secondary measures, the average pressure recorded inside the band at day 180 was 0.7 mmHg (a unit of pressure) in the conventional group and 15.8 mmHg in the intraband pressure group. The other secondary measure looked at the rate of weight loss per week: the conventional group averaged 0.18 kg per week, while the intraband pressure group averaged 0.43 kg per week. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Obesity Trial, Completed

NCT00960843
Completed Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are able to understand, follow instructions, and give your agreement to participate.
  • You are at least 18 years old when joining the trial.
  • Your BMI was between 35 and 55 before you had your gastric band device implanted.
  • You received a specific type of gastric band (called a SAGB VC) between 30 and 60 days before joining, and have not yet had your first band adjustment.
  • You are willing to be randomly assigned to one of two methods of band adjustment.
  • You are willing to attend monthly visits and possibly have the pressure inside your band measured (which requires access to the band's injection port).
  • You are willing to have up to 7 band adjustments over the 6-month study period.
  • You are able to sit upright at roughly a 90-degree angle for pressure measurements.
  • You are willing to come to appointments at around the same time of day as your first adjustment (within about 2 hours).
  • You are willing to have a limited imaging scan of your upper digestive system if the study doctor suspects a problem or if pressure readings are unusual (confirm with trial site).
  • You are willing to avoid taking any medications or supplements intended or known to cause weight loss.

Who may not be able to join:

  • You are currently known to be pregnant.
  • You have an ongoing, unresolved problem with your band being pierced or leaking.
  • You have an ongoing, unresolved issue with the band slipping, wearing into surrounding tissue, or the pouch above the band being stretched.
  • You have a diagnosed condition affecting the normal movement of your food pipe (esophagus) (confirm with trial site).
  • You have an ongoing, unresolved blockage or kinking in the band's tubing or port.
  • You currently have an infection at the injection port site.
  • You have previously had your gastric band revised or replaced.
  • You have a previously documented or ongoing widening of the food pipe (esophagus).
  • You have any other health condition that the study doctor believes could put your wellbeing at risk or affect the study results.
  • You are currently using, or use at any point during the study, any medications or supplements intended or known to cause weight loss.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Australian sites

Adelaide Bariatric Center, Bedford Park, South Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Ethicon Endo-Surgery
Registry
ClinicalTrials.gov
Start date
1 July 2009
Est. completion
1 November 2010

Where this trial is recruiting

🇦🇺 Australia 🇨🇿 Czechia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percent Excess Weight Change at Day 180

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov