ObesityPASNCT03570034
Obalon Balloon System Post-Approval Study
An observational study of Obesity, run by Obalon Therapeutics, Inc. at 15 sites in United States.
Trial summary
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Obalon Balloon System
- Type of treatment
- Medical device
- How many people
- 201 participants
- Where
- 15 sitesUnited States
- Study dates
- 15 Jun 2018to 13 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients aged 22 years and older, who are considered obesity Class I or II with a BMI of 30.0-40.0 kg/m2; and, have failed to lose weight through diet and exercise * Patients willing to commercially purchase the device.
Who may be able to join
- At least 22 years old
- BMI of 30-40 kg/m2
Who cannot join
- Contraindicated for the device
- Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.
- Known history of endocrine disorders affecting weight.
- Participation in any clinical study which could affect weight loss within the past year
- Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus
- Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Colorado Denver
Aurora, Colorado, 80045
JourneyLite Physicians
Cincinnati, Ohio, 45241
Minimally Invasive Surgical Associates
Dallas, Texas, 75208
Snow Bariatic Center
Flower Mound, Texas, 75028
Ultimate Bariatrics
Fort Worth, Texas, 76102
Smart Dimensions Weight Loss
Fountain Valley, California, 92694
Davtyan Medical Weight Loss and Wellness
Glendale, California, 91202
Lifetime Surgical Weight Loss
Los Gatos, California, 95032
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001
Greenwich Village Gastroenterology
Poughkeepsie, New York, 12601
New York Bariatric Group
Roslyn Heights, New York, 11577
Bariatric Medical Institute of Texas
San Antonio, Texas, 78258
SkyLex Health
Santa Monica, California, 90404
New Jersey Bariatric Center
Springfield, New Jersey, 07081
Artisan Cosmetic Surgery
Toledo, Ohio, 43617
About this study
Official title: Obalon Balloon System - Post-Approval Study
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
Read the detailed description
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal
- Conditions
- Obesity
- Being tested
- Obalon Balloon System
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obalon Balloon SystemDevice
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
| Study group | Role | What they receive |
|---|---|---|
| Obalon Balloon System | Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program Receives: Device: Obalon Balloon System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Event
Device or Procedure related Serious Adverse Event
Measured: 6-Month
Percentage of Patients with at least 5% TBWL
Percentage of Patients with at least 5% TBWL
Measured: 6-Month
Mean % TBWL
Mean %TBWL
Measured: 6-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Jun 2018
- Primary completion13 Sep 2020 (estimated)
- Study completion13 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obalon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shelby Sullivan, MD, FACG, Principal investigator, University of Colorado, DenverRachel Moore, MD, FACS, FASMBS, Principal investigator, Surgical Specialist of Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570034
- Sponsor's protocol ID
- PTL-7500-0011
- Acronym
- PAS
- Status last verified
- Apr 2020
- First submitted
- 15 Jun 2018
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obalon Balloon System - Post-Approval Study
- ClinicalTrials.gov ID
- NCT03570034
- Acronym / sponsor ID
- PAS / PTL-7500-0011
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Obalon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 13 Sep 2020 (estimated)
- Study completion
- 13 Mar 2021 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
Detailed description
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obalon Balloon System | – | Device: Obalon Balloon SystemObalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients aged 22 years and older, who are considered obesity Class I or II with a BMI of 30.0-40.0 kg/m2; and, have failed to lose weight through diet and exercise * Patients willing to commercially purchase the device.
Key inclusion criteria (2 listed)
- At least 22 years old
- BMI of 30-40 kg/m2
Key exclusion criteria (6 listed)
- Contraindicated for the device
- Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.
- Known history of endocrine disorders affecting weight.
- Participation in any clinical study which could affect weight loss within the past year
- Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus
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 Balloon SystemObalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program | Device | Obalon Balloon System |
Primary outcome
Serious Adverse Event
Time frame: 6-Month
Device or Procedure related Serious Adverse Event
Percentage of Patients with at least 5% TBWL
Time frame: 6-Month
Percentage of Patients with at least 5% TBWL
Mean % TBWL
Time frame: 6-Month
Mean %TBWL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Shelby Sullivan, MD, FACG principal investigator
University of Colorado, Denver
Rachel Moore, MD, FACS, FASMBS principal investigator
Surgical Specialist of Louisiana
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. 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. 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?
Results are not available in the source record.
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?
Serious Adverse Event (time frame: 6-Month). The study lists 3 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 30 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.