ObesitySMARTNCT02235870

Obalon Balloon System Pivotal IDE (SMART) Trial

A study testing Obalon Intragastric Balloons and Nutrition and Lifestyle Program in people with Obesity, run by Obalon Therapeutics, Inc. at 15 sites 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

This pivotal trial of the Obalon Balloon System is intended to generate safety and effectiveness data required to support a future marketing application. The trial has been designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition and lifestyle behavior modification program. Read more about this study

Who is it for?: Ages 22 to 64 years
Conditions the study is for: Obesity
What is being tested?: Obalon Intragastric Balloons and Nutrition and Lifestyle Program
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 711 participants
Where: 15 sitesUnited States
Study dates: Feb 2015to May 2016
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 22 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female between the ages of 22-64 years
Current BMI of 30.0 - 40 kg/m2
Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet
Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period
Willing to avoid non-commercial air travel and scuba diving during the entire study period
Willing to avoid medications or other substances known to effect weight changes during the study

Show all 9Show fewer

Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications known to be gastric irritants during the study
Willing to use contraception and avoid pregnancy during the study if the subject is female with child bearing potential
Willing to provide written informed consent

Who cannot join

Significant weight loss in the past 12 months
Use of medications or other substances known to induce weight gain or weight loss
Participation in any clinical study at the start of this trial or in the last year
Known history of endocrine disorders affecting weight
Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV
Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders

Show all 31Show fewer

Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study
Prior use of any weight loss medical device
Known history of structural or functional disorders of the esophagus
Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
Known history of structural or functional disorders of the stomach
Known history of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety
Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract
Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities
Type 1 diabetes
Type 2 diabetes requiring insulin or other hypoglycemic oral agents.
Experienced a myocardial infarction, has a known history of angina, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition
Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic).
End stage renal disease or requiring hemodialysis within the past 6 months
Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study period
Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying
Subjects requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood
Untreated or unstable alcohol or illicit drug addiction
Known history of allergies to any component of the device materials
Currently pregnant or breastfeeding or intention of becoming pregnant during the study
Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff
Subject is a close relative of another subject already enrolled in the study.
Any other condition that, in the opinion of the investigator, would interfere with subject participation, may confound the study results, or interfere with compliance with the study (e.g., psychosocial issues).

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Anaheim Clinical Trials
Anaheim, California
Chattanooga Bariatrics
Chattanooga, Tennessee
Southern California Research Center
Coronado, California
Bariatric Institute of Greater Chicago
Hinsdale, Illinois
Houston Methodist Research Institute
Houston, Texas
Saint Luke's Hospital of Kansas City
Kansas City, Missouri
Midsouth Bariatrics
Memphis, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee
West Penn Hospital
Pittsburgh, Pennsylvania
University of Utah Hospital
Salt Lake City, Utah
HonorHealth Research Institute
Scottsdale, Arizona
Virginia Mason Medical Center
Seattle, Washington
Washington University Hospital in St. Louis
St Louis, Missouri
Stony Brook Medicine
Stony Brook, New York
Endoscopic Microsurgery Associates
Towson, Maryland

Other trials in United States

About this study

Official title: The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial

Weight loss will be evaluated after the 6-month course to determine if a specific predefined superiority margin can be achieved in the device group compared to a sham-control group.

Conditions: Obesity
Being tested: Obalon Intragastric Balloons, Sham Device, Nutrition and Lifestyle Program
Keywords: Weight Loss, Obesity, BMI
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.

Obalon Intragastric BalloonsDevice
Intragastric Balloon System to aid in portion control.
Sham DeviceDevice
Sham Intragastric Balloon
Nutrition and Lifestyle ProgramBehavioural
Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.

Study groups in NCT02235870
Study group	Role	What they receive
Treatment Group	Active comparator	In accordance with the randomization assignment, treatment arm subjects will receive a 6-month course of Balloon therapy with a nutrition and lifestyle program. Balloon treatment consists of placement of 3 balloons Obalon Intragastric Balloons in the first 3 months of therapy. Receives: Device: Obalon Intragastric Balloons; Behavioral: Nutrition and Lifestyle Program
Control Group	Sham comparator	Control arm subjects will receive a single 6-month course of sham device therapy with a nutrition and lifestyle program. Sham treatment consists of placement of 3 shams in the first 3 months of therapy. Receives: Device: Sham Device; Behavioral: Nutrition and Lifestyle Program

What is being measured

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

Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin
Measured: 24 Weeks
Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%
Measured: 6 months

Timeline

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

Feb 2015May 2016

First posted10 Sep 2014 (estimated)
Study startFeb 2015
Primary completionNov 2015
Study completionMay 2016

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 711 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02235870
Sponsor's protocol ID: PTL-1100-0013
Acronym: SMART
Status last verified: Feb 2018
First submitted: 8 Sep 2014
Last updated: 8 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Six-Month Adjunctive Weight Reduction Therapy (SMART) Trial
ClinicalTrials.gov ID: NCT02235870
Acronym / sponsor ID: SMART / PTL-1100-0013
Conditions: Obesity
Keywords: Weight Loss, Obesity, BMI
Study type: Interventional
Recruitment status: Completed
Enrolment: 711 participants (actual)
Lead sponsor: Obalon Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Nov 2015 (actual)
Study completion: May 2016 (actual)
First posted: 10 Sep 2014 (estimated)
Results: Posted 8 Mar 2018

Clinical summary

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

Weight loss will be evaluated after the 6-month course to determine if a specific predefined superiority margin can be achieved in the device group compared to a sham-control group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment Group	Active comparator	Device: Obalon Intragastric Balloons, Behavioral: Nutrition and Lifestyle ProgramIn accordance with the randomization assignment, treatment arm subjects will receive a 6-month course of Balloon therapy with a nutrition and lifestyle program. Balloon treatment consists of placement of 3 balloons Obalon Intragastric Balloons in the first 3 months of therapy.
Control Group	Sham comparator	Device: Sham Device, Behavioral: Nutrition and Lifestyle ProgramControl arm subjects will receive a single 6-month course of sham device therapy with a nutrition and lifestyle program. Sham treatment consists of placement of 3 shams in the first 3 months of therapy.

Who may qualify

Ages: 22 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Male or female between the ages of 22-64 years
Current BMI of 30.0 - 40 kg/m2
Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet
Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period
Willing to avoid non-commercial air travel and scuba diving during the entire study period

Key exclusion criteria (31 listed)

Significant weight loss in the past 12 months
Use of medications or other substances known to induce weight gain or weight loss
Participation in any clinical study at the start of this trial or in the last year
Known history of endocrine disorders affecting weight
Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV

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
Obalon Intragastric BalloonsIntragastric Balloon System to aid in portion control.	Device	Treatment Group
Sham DeviceSham Intragastric Balloon	Device	Control Group
Nutrition and Lifestyle ProgramNutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.	Behavioural	Control Group, Treatment Group

Primary outcome

Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
Time frame: 24 Weeks
Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin
Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
Time frame: 6 months
Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%

Results and safety

Results posted to the registry on 8 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Obalon Treatment Group	198	160
Sham Control Group	189	128

Primary outcome: Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups

Time frame: 24 Weeks. Least squares mean (Standard Error). Unit: %TBL

Measure	Obalon Treatment Group n = 185	Sham Control Group n = 181
Value	6.86 (0.37)	3.59 (0.37)

Obalon Treatment Group vs Sham Control Group: Least-Square Mean Difference: 3.28 (95% CI 2.24 to 4.32), p = 0.0261, ANCOVA

Population analysed: Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks

Primary outcome: Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Obalon Treatment Group n = 185
Value	120

Obalon Treatment Group: Exact Confidence Interval: 64.9 (95% CI 57.5 to 71.7), p <0.0001, Exact Test

Population analysed: Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks

Adverse events

Time frame: Six months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treated Subjects	7 of 336 (2.1%)	321 of 336 (95.5%)	0 of 336
Control Subjects	5 of 359 (1.4%)	221 of 359 (61.6%)	0 of 359

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Amy VandenBerg study chair

Obalon Therapeutics, Inc.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Obalon Intragastric Balloons and Nutrition and Lifestyle Program in people with Obesity, run by Obalon Therapeutics, Inc. at 15 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 9 inclusion and 31 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 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 8 Mar 2018). 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?

Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups (time frame: 24 Weeks). 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 NCT02235870.

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 8 Mar 2018.