ObesityNTS PASNCT04095481
Obalon Navigation/Touch System Post-Approval Study
An observational study of Obesity, run by Obalon Therapeutics, Inc. at 2 sites in United States.
Trial summary
Post-approval study for the Obalon Navigation/Touch System (NTS) 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 Navigation/Touch System
- Type of treatment
- Medical device
- How many people
- 1,600 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Dec 2019to 30 May 2023
- 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 22 years and older with a starting therapy BMI of 30.0-40.0 kg/m2 and who commercially purchased the Obalon Balloon device.
Who may be able to join
- Ages 22 years and older
- Starting or current therapy BMI of 30.0-40.0 kg/m2
- Commercially purchased the Obalon Balloon Device
Who cannot join
- Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder 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 including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.
- Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Ultimate Bariatrics - Flower Mound
Flower Mound, Texas, 75028
Bryanna Henry, 8177834395, BHenry@IAmYou.com
Robert Snow, DO, FACOS, FASMBS
- Recruiting
Ultimate Bariatrics - Fort Worth
Fort Worth, Texas, 76102
Bryanna Henry, 817-850-1100, bhenry@iamyou.com
Adam B Smith, DO, FACOS
About this study
Post-approval study for the Obalon Navigation/Touch System (NTS)
Read the detailed description
The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.
- Conditions
- Obesity
- Being tested
- Obalon Navigation/Touch 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 Navigation/Touch SystemDevice
The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon
| Study group | Role | What they receive |
|---|---|---|
| Obalon NTS | Patients who commercially purchased the NTS Compatible Obalon Balloon System Receives: Device: Obalon Navigation/Touch System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Inflation
Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
Measured: Up to 20 Weeks
System Success
Percentage of appropriate inflation in the stomach with the use of NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal
Measured: Up to 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start3 Dec 2019
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obalon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095481
- Sponsor's protocol ID
- PTL-7410-0007
- Acronym
- NTS PAS
- Status last verified
- Dec 2019
- First submitted
- 26 Aug 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obalon Navigation/Touch System Post-Approval Study
- ClinicalTrials.gov ID
- NCT04095481
- Acronym / sponsor ID
- NTS PAS / PTL-7410-0007
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Obalon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 19 Sep 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.
Post-approval study for the Obalon Navigation/Touch System (NTS)
Detailed description
The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obalon NTS | – | Device: Obalon Navigation/Touch SystemPatients who commercially purchased the NTS Compatible Obalon Balloon System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 22 years and older with a starting therapy BMI of 30.0-40.0 kg/m2 and who commercially purchased the Obalon Balloon device.
Key inclusion criteria (3 listed)
- Ages 22 years and older
- Starting or current therapy BMI of 30.0-40.0 kg/m2
- Commercially purchased the Obalon Balloon Device
Key exclusion criteria (4 listed)
- Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation or any other disorder 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 including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.
- Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
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 Navigation/Touch SystemThe NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon | Device | Obalon NTS |
Primary outcome
Esophageal Inflation
Time frame: Up to 20 Weeks
Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
System Success
Time frame: Up to 20 Weeks
Percentage of appropriate inflation in the stomach with the use of NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
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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.
2 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 2 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 3 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Amy VandenBerg (844.362.2566, ClinicalAffairs@obalon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Inflation (time frame: Up to 20 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?
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 23 Dec 2019.