Obalon Navigation/Touch System Post-Approval Study
NTS PAS
1 other identifier
observational
1,600
1 country
2
Brief Summary
Post-approval study for the Obalon Navigation/Touch System (NTS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedStudy Start
First participant enrolled
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedDecember 23, 2019
December 1, 2019
3.5 years
August 26, 2019
December 19, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Esophageal Inflation
Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
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
Up to 20 Weeks
Study Arms (1)
Obalon NTS
Patients who commercially purchased the NTS Compatible Obalon Balloon System
Interventions
The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon
Eligibility Criteria
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.
You may qualify if:
- Ages 22 years and older
- Starting or current therapy BMI of 30.0-40.0 kg/m2
- Commercially purchased the Obalon Balloon Device
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ultimate Bariatrics - Flower Mound
Flower Mound, Texas, 75028, United States
Ultimate Bariatrics - Fort Worth
Fort Worth, Texas, 76102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
September 19, 2019
Study Start
December 3, 2019
Primary Completion
May 30, 2023
Study Completion
May 30, 2023
Last Updated
December 23, 2019
Record last verified: 2019-12