Obesity, MorbidNCT04209842
Effectiveness Gastric Balloon in Obese Adolescents
A study testing gastric balloon in people with Obesity, Morbid, run by Stanford University at 1 site in United States.
Trial summary
Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- gastric balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Aug 2026
- Phase
- Interventional
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI > 3.5 SD)
- Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised
Who cannot join
- Previous esophageal or gastric surgery or history of intestinal obstruction;
- History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
- Hiatus hernia >5 cm or <5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
- History of significant psychological disorder (permission sought from lead care giver).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.
- Conditions
- Obesity, Morbid
- Being tested
- gastric balloon
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric balloonDevice
Also called Orbera
non surgical weight loss via placement of gastric balloon
| Study group | Role | What they receive |
|---|---|---|
| gastric ballon placement | Experimental | will receive gastric balloon placed via endoscopy Receives: Device: gastric balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline weight
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 posted24 Dec 2019
- Study startSep 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Gugig, Stanford University
- Investigators
- Roberto Gugig, MD, Principal investigator, Stanford UniversityMonique T Barakat, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209842
- Sponsor's protocol ID
- 52936
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2019
- Last updated
- 21 Dec 2023
- 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 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
- ClinicalTrials.gov ID
- NCT04209842
- Acronym / sponsor ID
- 52936
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Dec 2019 (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.
Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric ballon placement | Experimental | Device: gastric balloonwill receive gastric balloon placed via endoscopy |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI > 3.5 SD)
- Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised
Key exclusion criteria (4 listed)
- Previous esophageal or gastric surgery or history of intestinal obstruction;
- History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
- Hiatus hernia >5 cm or <5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
- History of significant psychological disorder (permission sought from lead care giver).
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 |
|---|---|---|
| gastric balloonAlso: Orberanon surgical weight loss via placement of gastric balloon | Device | gastric ballon placement |
Primary outcome
change from baseline weight
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- 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.
Roberto Gugig, MD principal investigator
Stanford University
Monique T Barakat, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric balloon in people with Obesity, Morbid, run by Stanford University at 1 site 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 4 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change from baseline weight (time frame: 6 months). 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 21 Dec 2023.