ObesityNCT03688256
Obalon US Commercial Registry
An observational study of Obesity, run by Surgical Specialists of Louisiana.
Trial summary
Retrospective study of the data reported in the Obalon US Commercial Registry Read more about this study
- Who is it for?
- Any ageHealthy 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
- 1,343 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 28 Aug 2018
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Obalon Commercial Patients
Who may be able to join
- Started Obalon Balloon Therapy between Jan.-Dec. 2017
- Weight loss data through balloon removal
- BMI >25kg/m2
Who cannot join
None listed.
About this study
Official title: Obalon Balloon System: Real-World Evidence Commercial Site Registry
Retrospective study of the data reported in the Obalon US Commercial Registry
Read the detailed description
Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.
- 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
6 month Obalon Intragastric Balloons
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome - Serious Adverse Events
Percentage of Patients with Serious Adverse Events
Measured: 6 months
Primary Effectiveness Outcome - Weight Loss Metrics
Mean Weight Loss Metrics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Jan 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,343 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Surgical Specialists of Louisiana
- Sponsor type
- University, hospital or other
- Collaborators
- Obalon Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688256
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obalon Balloon System: Real-World Evidence Commercial Site Registry
- ClinicalTrials.gov ID
- NCT03688256
- Acronym / sponsor ID
- 01
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,343 participants (actual)
- Lead sponsor
- Surgical Specialists of LouisianaUniversity, hospital or other
- Collaborators
- Obalon Therapeutics, Inc.
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 28 Sep 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.
Retrospective study of the data reported in the Obalon US Commercial Registry
Detailed description
Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obalon Commercial Patients
Key inclusion criteria (3 listed)
- Started Obalon Balloon Therapy between Jan.-Dec. 2017
- Weight loss data through balloon removal
- BMI >25kg/m2
Key exclusion criteria (0 listed)
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 System6 month Obalon Intragastric Balloons | Device | – |
Primary outcome
Primary Safety Outcome - Serious Adverse Events
Time frame: 6 months
Percentage of Patients with Serious Adverse Events
Primary Effectiveness Outcome - Weight Loss Metrics
Time frame: 6 months
Mean Weight Loss Metrics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Surgical Specialists of Louisiana.
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 3 inclusion and 0 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 28 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Safety Outcome - Serious Adverse Events (time frame: 6 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?
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 28 Sep 2018.