ObesityNCT01673698
A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
A study testing ReShape Duo balloon, Diet counseling and Exercise counseling in people with Obesity, run by ReShape Lifesciences at 8 sites in United States.
Trial summary
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- ReShape Duo balloon, Diet counseling and Exercise counseling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2012to Sep 2014
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 21 to 60 years of age
- Body Mass Index (BMI) ≥ 30 kg/m^2 and ≤ 40 kg/m^2
- At least 5 years of obesity (with BMI ≥ 30)
- Stable weight, defined as a subject who has not gained or lost ≥ 5% of body weight in the 3 months preceding the screening assessment
- Failure to lose weight, within the 36 months preceding the screening date, after participation in either of the following:
- A medically or commercially supervised weight loss program involving regular counseling regarding both diet and exercise.
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- Use of a United States Food and Drug Administration (FDA)-approved diet drug
- The presence of one or more obesity-related comorbid conditions
- Willing and able to provide Informed Consent
- Willing and able to comply with study procedures and visit schedules as specified by the protocol
- If female, the patient must
- be postmenopausal for at least 1 year OR
- be surgically sterile, OR
- if of child bearing potential, must be practicing birth control, be willing to avoid pregnancy for the year of study participation, have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline
- Residing within a reasonable distance from the Investigator's treating office and able and willing to travel to the Investigator's office to complete all routine follow-up visits.
Who cannot join
- History of and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract
- Clinically significant and uncontrolled/unstable hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, psychiatric, respiratory, endocrine, or cardiovascular system diseases
- Significant acute and/or chronic infections of any kind.
- Severe coagulopathy, hepatic insufficiency or cirrhosis
- Uncontrolled or severe asthma, or any asthma requiring or likely to require inhaled steroid therapy during the anticipated duration of trial participation
- Severe obstructive sleep apnea
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- Incompletely controlled hypothyroidism or hyperthyroidism
- Severe systemic disease [consistent with an ASA (American Society of Anesthesia) Physical Status Classification Score of 3 or greater]
- Eating disorders, especially binge eating
- Inability to walk 200 yards without assistance
- Known allergies to any of the device materials or accessories, i.e. silicone, methylene blue, corn starch
- Active drug or alcohol addiction within 12 months of enrollment
- Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months
- Depressive disorder with total Beck Depression Inventory (BDI) score > 16 points, and/or BDI affective subscale score > 7 points at screening
- Ongoing treatment, or anticipated need for such treatment, with anticoagulants, known gastric irritants such as aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) or agents that can promote gastrointestinal bleeding, within 1 month prior to enrollment, or unwillingness to forego these medications during the study period
- Participation within 60 days of screening date in previous or ongoing clinical trial or current usage of an investigational drug or device
- Any use of an intragastric device prior to this study.
- Genetically caused obesity, such as Prader-Willi syndrome
- Any prior bariatric surgery or likely to undergo bariatric surgery during study follow-up period
- Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study, including online or smart phone applications to track or modify food intake, exercise regimens or weight
- Chronic opiate use (> 3 months continuous use) or likely need for opiate use during study participation
- Contraindication or allergy to, or unwillingness to use, proton pump inhibitor medication throughout study follow-up duration-Pregnancy, breast feeding, or intention of becoming pregnant during the study
- Any screening laboratory values outside of the normal range deemed clinically significant by the Investigator
- Anemia defined as either:
- Hemoglobin (Hgb) value for females of < 11.0 g/dl, for males < 12.0 g/dl
- Abnormal red cell indices and iron deficiency
- Smoking cessation within 3 months of study entry or plans to quit smoking during the study
- Major surgery, open biopsy or significant traumatic injury within 3 months prior to enrollment.
- History of significant adverse experience with sedation or anesthesia
- Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with study procedures
- Any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements, including:
- Inability or unwillingness to sign the patient informed consent document.
- Inability to participate in all necessary study activities due to physical or mental limitations.
- Inability or unwillingness to return for all required follow-up visits.
- Employees/family members of ReShape Medical® or any of its affiliates or contractors
- Employees/family members of the Investigator, sub-Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed
- An immediate family member (by marriage or blood relationship) of another subject already enrolled in the REDUCE Pivotal Trial
- Endoscopic exclusion criteria:
- Peptic ulcerations
- Clinically significant hiatal hernia (> 3 cm)
- Patulous pyloric channel
- Erosive esophagitis
- Varices
- Angiectasias
- Barrett's esophagus
- Esophageal stricture
- Gastric mass
- Any other subject characteristic that would prevent the successful insertion of a ReShape Duo™ or that in the opinion of the Investigator preclude safe use of the ReShape Duo™
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Hamilton Medical Center
Dalton, Georgia, 30720
University of TX Health Science Center at Houston
Houston, Texas, 77030
Marquette General Surgical Weight Loss Center
Marquette, Michigan, 49855
Midsouth Bariatrics
Memphis, Tennessee, 38120
University of Minnesota/Department of Gastrointestinal Surgery
Minneapolis, Minnesota, 55455
Scottsdale Healthcare
Scottsdale, Arizona, 85258
Greenville Hospital System
Simpsonville, South Carolina, 29680
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
- Conditions
- Obesity
- Being tested
- ReShape Duo balloon, Diet counseling, Exercise counseling
- Keywords
- obesity, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReShape Duo balloonDevice
Diet counselingOther
Exercise counselingOther
| Study group | Role | What they receive |
|---|---|---|
| ReShape Duo Balloon | Active comparator | ReShape Duo Balloon Receives: Device: ReShape Duo balloon; Other: Diet counseling; Other: Exercise counseling |
| Sham Comparator | Sham comparator | Sham Comparator Receives: Other: Diet counseling; Other: Exercise counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Measured: Week 24
Treatment Group Responder Rate Dichotomized at 25% EWL
An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.
Measured: 24 weeks
Secondary outcomes (1)
Weight Loss Maintenance Six Months Following Device Removal
Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionSep 2014
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lehmann, MD, MPH, Study director, Lehmann ConsultingJaime Ponce, MD, Principal investigator, Hamilton Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673698
- Sponsor's protocol ID
- The REDUCE Pivotal Trial
- Status last verified
- Nov 2015
- First submitted
- 15 Aug 2012
- Last updated
- 7 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
- ClinicalTrials.gov ID
- NCT01673698
- Acronym / sponsor ID
- The REDUCE Pivotal Trial
- Conditions
- Obesity
- Keywords
- obesity, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Aug 2012 (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.
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReShape Duo Balloon | Active comparator | Device: ReShape Duo balloon, Other: Diet counseling, Other: Exercise counselingReShape Duo Balloon |
| Sham Comparator | Sham comparator | Other: Diet counseling, Other: Exercise counselingSham Comparator |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Patients 21 to 60 years of age
- Body Mass Index (BMI) ≥ 30 kg/m^2 and ≤ 40 kg/m^2
- At least 5 years of obesity (with BMI ≥ 30)
- Stable weight, defined as a subject who has not gained or lost ≥ 5% of body weight in the 3 months preceding the screening assessment
- Failure to lose weight, within the 36 months preceding the screening date, after participation in either of the following:
Key exclusion criteria (48 listed)
- History of and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract
- Clinically significant and uncontrolled/unstable hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, psychiatric, respiratory, endocrine, or cardiovascular system diseases
- Significant acute and/or chronic infections of any kind.
- Severe coagulopathy, hepatic insufficiency or cirrhosis
- Uncontrolled or severe asthma, or any asthma requiring or likely to require inhaled steroid therapy during the anticipated duration of trial participation
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 Duo balloon | Device | ReShape Duo Balloon |
| Diet counseling | Other | ReShape Duo Balloon, Sham Comparator |
| Exercise counseling | Other | ReShape Duo Balloon, Sham Comparator |
Primary outcome
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
Time frame: Week 24
An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Treatment Group Responder Rate Dichotomized at 25% EWL
Time frame: 24 weeks
An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.
1 secondary outcome
Weight Loss Maintenance Six Months Following Device Removal
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obesity
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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.
John Lehmann, MD, MPH study director
Lehmann Consulting
Jaime Ponce, MD principal investigator
Hamilton Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReShape Duo balloon, Diet counseling and Exercise counseling in people with Obesity, run by ReShape Lifesciences at 8 sites 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 15 inclusion and 48 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24 (time frame: Week 24). 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?
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 7 Dec 2015; AzTrials last refreshed its copy on 28 Oct 2026.