Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585371
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Evaluation of a 6-month Intragastric Balloon
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of a 6-month Intragastric Balloon
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-market observational adaptive single-arm clinical study to evaluate the percentage of total weight loss after treatment with an intragastric balloon Patients will be followed for 6 months after the device is installed
Detailed Description:
Forty-six overweight patients over 18 years of age with a BMI of 27 kgm2 or greater who are considered suitable for intragastric balloon placement will be included The primary outcome will be the assessment of the percentage of total weight loss WL at 6 months Patients will be screened in an outpatient setting at the participating research center All participants who meet the eligibility criteria will be invited to participate in the study which includes a screening visit standard intragastric balloon placement procedure and follow-up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None