ObesityNCT01061385

The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

A study testing ReShape Intragastric Balloon in people with Obesity, run by ReShape Lifesciences.

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

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: ReShape Intragastric Balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Feb 2010to Jul 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 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects aged ≥ 20 years and ≤ 60 years;
At screening, body mass index (BMI) ≥ 30 Kg/m^2 and ≤ 40 Kg/m^2;
Have a history of obesity (BMI ≥ 30 kg/m^2) for at least 6 months and have failed other weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
Subject is willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
Subject has reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 24 weeks);
At screening, total Beck Depression Inventory (BDI) score < 12 points, and BDI affective subscale score < 7 points.

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Subject is able to follow requirements outlined in the protocol, including complying with the visit schedule, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, electrocardiography (ECG), and/or clinical laboratory testing;
Subject is willing to take prescribed proton pump inhibitors (PPIs);
Subject is able to provide written informed consent;
If female of child-bearing potential, the subject is willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study.

Who cannot join

Participating in an organized weight loss program (e.g., Weight Watchers);
Parkinson's disease;
Chronic narcotic use;
Clinically relevant abdominal adhesions (e.g., history of bowel obstruction);
History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy and cholecystectomy), obstruction, and/or adhesive peritonitis;
History or symptoms of clinically significant esophageal or GI motility disorders;

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A hormonal or genetic cause for subject's obesity;
A history of myocardial infarction in the previous 6 months, current New York Heart Association (NYHA) Functional Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);
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;
History or symptoms of uncontrolled or unstable thyroid disease;
Subjects with a positive breath test for Helicobacter pylori at screening;
History or symptoms in the past 12 months of significant irritable bowel disease, peritonitis, active esophagitis, gastric or duodenal ulceration, or GI bleeding;
History of esophageal and/or stomach cancer.
Type I diabetes;
Placement of previous intragastric balloon or similar device with associated adverse; or any endogastric procedure within the last 6 months;
Ongoing treatment with anticoagulants, steroids, aspirin (> 81 mg/day), non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants or to reduce GI motility, and 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);
Known allergy to silicone;
A history of anemia
Participation in another investigational trial within 1 month of screening or planned enrollment during the study period.
Presence of peptic ulcerations, hiatal hernia (> 2 cm), patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus or other findings deemed exclusionary in the opinion of the investigator.

About this study

Official title: IDE G090121 A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Intragastric Balloon (RIBTM) in Obese Subjects

The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. The study device is designed to occupy space within the stomach and induce satiety. After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (with endoscopic placement of study device) or the control group (no placement of study device) on an unblinded basis. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48 week study duration.

Conditions: Obesity
Being tested: ReShape Intragastric Balloon, Control Arm
Medical subject headings: Obesity

What participants receive

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

ReShape Intragastric BalloonDevice
Placement of ReShape Medical Intragastric Balloon for twenty four weeks
Control ArmOther
Behavioral Modification (Diet and exercise counseling) alone

Study groups in NCT01061385
Study group	Role	What they receive
ReShape Intragastric Balloon	Experimental	Patients receiving the ReShape Intragastric Balloon Receives: Device: ReShape Intragastric Balloon
Control Arm	Other	Weight loss using behavior modification (diet and exercise counseling) alone Receives: Other: Control Arm

What is being measured

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

%Excess Weight Loss
the difference between the %EWL between treatment and control groups must be clinically significant
Measured: 36 Weeks

Secondary outcomes (1)

Percentage of Subjects With >=25% Excess Weight Loss (EWL)
a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months
Measured: 12 months

Timeline

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

Feb 2010Jul 2011

First posted3 Feb 2010 (estimated)
Study startFeb 2010
Primary completionMar 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01061385
Sponsor's protocol ID: REDUCE-IDE
Status last verified: Apr 2016
First submitted: 1 Feb 2010
Last updated: 13 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IDE G090121 A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Intragastric Balloon (RIBTM) in Obese Subjects
ClinicalTrials.gov ID: NCT01061385
Acronym / sponsor ID: REDUCE-IDE
Conditions: Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: ReShape LifesciencesIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Mar 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 3 Feb 2010 (estimated)
Results: Posted 7 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ReShape Intragastric Balloon	Experimental	Device: ReShape Intragastric BalloonPatients receiving the ReShape Intragastric Balloon
Control Arm	Other	Other: Control ArmWeight loss using behavior modification (diet and exercise counseling) alone

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Subjects aged ≥ 20 years and ≤ 60 years;
At screening, body mass index (BMI) ≥ 30 Kg/m^2 and ≤ 40 Kg/m^2;
Have a history of obesity (BMI ≥ 30 kg/m^2) for at least 6 months and have failed other weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
Subject is willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
Subject has reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 24 weeks);

Key exclusion criteria (24 listed)

Participating in an organized weight loss program (e.g., Weight Watchers);
Parkinson's disease;
Chronic narcotic use;
Clinically relevant abdominal adhesions (e.g., history of bowel obstruction);
History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy and cholecystectomy), obstruction, and/or adhesive peritonitis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ReShape Intragastric BalloonPlacement of ReShape Medical Intragastric Balloon for twenty four weeks	Device	ReShape Intragastric Balloon
Control ArmBehavioral Modification (Diet and exercise counseling) alone	Other	Control Arm

Primary outcome

%Excess Weight Loss
Time frame: 36 Weeks
the difference between the %EWL between treatment and control groups must be clinically significant

1 secondary outcome

Percentage of Subjects With >=25% Excess Weight Loss (EWL)
Time frame: 12 months

Results and safety

Results posted to the registry on 7 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ReShape Intragastric Balloon	21	20
Control Arm	9	8

Primary outcome: %Excess Weight Loss

Time frame: 36 Weeks. Mean (Standard Deviation). Unit: percent excess weight loss

Measure	ReShape Intragastric Balloon n = 21	Control n = 9
Value	20.2 (16.7)	12.7 (19.3)

ReShape Intragastric Balloon vs Control: Mean Difference (Net): 7.5 (95% CI -6.8 to 21.7), p = 0.2922, t-test, 1 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ReShape Intragastric Balloon	3 of 21 (14.3%)	21 of 21 (100%)	Not reported
Control Arm	0 of 9 (0%)	6 of 9 (66.7%)	Not reported

Limitations and caveats (from the sponsor): Given the small sample size of this feasibility cohort, it was not expected to show significant effectiveness.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Lou Mooney study director

ReShape Medical

Questions about this trial

What is this clinical trial studying?

A study testing ReShape Intragastric Balloon in people with Obesity, run by ReShape Lifesciences.

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 10 inclusion and 24 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

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 7 Dec 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?

%Excess Weight Loss (time frame: 36 Weeks). 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 NCT01061385.

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 13 May 2016.