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ObesityNCT00730327

A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

A study testing BioEnterics® Intragastric Balloon and Behavioral modification in people with Obesity, run by Apollo Endosurgery, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
BioEnterics® Intragastric Balloon and Behavioral modification
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
448 participants
Where
1 siteUnited States
Study dates
Jun 2008to Oct 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a BMI ≥ 30 and ≤ 40;
  • Be male or female, between 18 and 65 years of age, inclusive;
  • Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
  • Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
  • Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 26 weeks);
  • Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing;
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  • Must be willing to take prescribed proton pump inhibitors (PPIs)and other medications as prescribed by the investigator;
  • Be able to provide written informed consent and authorization for use and release of Health and Research Study Information;
  • Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.

Who cannot join

  • Any surgery of the foregut excluding uncomplicated cholecystectomy
  • History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy), GI obstruction, adhesive peritonitis, and/or hiatal hernia (>/= 2 cm);
  • A patulous pyloric channel;
  • History or symptoms of esophageal or GI motility disorders (not just those with <40%) as these patients are particularly susceptible to the development of esophagitis;
  • History or previous symptoms of delayed Gastric Emptying (GE) and/or delayed GE having been documented on a previously performed gastric scintigraphy study or another previously performed diagnostic study such as a UGI x-ray series;
  • Current symptoms of delayed GE;
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  • A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);
  • Anemia defined as a hemoglobin value for females of <11.3 g/dl and for males < 13.0 g/dl;
  • History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
  • History or symptoms of inflammatory bowel disease, such as Crohn's disease or Ulcerative Colitis;
  • History or symptoms of uncontrolled or unstable thyroid disease;
  • Subjects with a positive test for Helicobacter pylori (H.p.) at screening; subjects may participate in the study if, prior to randomization, they are treated with a pharmacological regimen designed to eradicate their H.p. and subsequently have a negative H.p. breath test indicating that the H.p. has been eradicated
  • History or symptoms in the past 24 months of significant irritable bowel syndrome, peritonitis, active esophagitis, gastritis and/or duodenitis, gastric or duodenal ulceration, GI hemorrhage, or GI bleeding;
  • Type I diabetes;
  • Placement of previous intragastric balloon or similar device;
  • Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastroduodenal mucosal irritants or to reduce GI motility, and/or an unwillingness to discontinue the use of these concomitant medications;
  • Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study;
  • Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia;
  • Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential;
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study;
  • Poor general health, presence of a specific condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or placement of the BIB, or may interfere significantly with the subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history within the last 5 years)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Apollo Endosurgery

    Austin, Texas, 78746

Other trials in United States

About this study

Official title: Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.

Conditions
Obesity
Being tested
BioEnterics® Intragastric Balloon, Behavioral modification
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioEnterics® Intragastric BalloonDevice

    Also called BIB®

    Inflatable balloon inserted into the stomach.

  • Behavioral modificationOther

    Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise

Study groups in NCT00730327
Study groupRoleWhat they receive
BIB®ExperimentalReceives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
Receives: Device: BioEnterics® Intragastric Balloon; Other: Behavioral modification
ControlOtherControl arm receives the Behavioral modification intervention only.
Receives: Other: Behavioral modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Excess Weight Loss (%EWL)

    The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.

    Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.

    Measured: 9 months

  2. Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group

    The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.

    %EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.

    Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.

    Measured: 9 months

Secondary outcomes (4)

  1. Percent of Participants With Comorbid Conditions

    The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.

    Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.

    Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.

    Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female).

    Measured: Baseline, Week 26, Week 39, Week 52

  2. Change in Quality of Life (SF-36)

    The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.

    Measured: Baseline, Week 39

  3. Change in Quality of Life (IWQOL-Lite)

    The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.

    Measured: Baseline, Week 26, Week 39, Week 52

  4. Change in Participant Depression (Beck Depression Inventory II)

    Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).

    Measured: Baseline, Week 26, Week 39, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00730327
Sponsor's protocol ID
IB-005
Status last verified
Oct 2015
First submitted
6 Aug 2008
Last updated
6 Nov 2015
Data monitoring committee
No

Publications

  • Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.

    PubMed 27465076

Questions about this trial

What is this clinical trial studying?

A study testing BioEnterics® Intragastric Balloon and Behavioral modification in people with Obesity, run by Apollo Endosurgery, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Excess Weight Loss (%EWL) (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00730327, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.

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