Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT03079557
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2017-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Pilot for the ReBOO-trial
Sponsor:
St. Olavs Hospital
Organization:
Study Overview
Official Title:
A Non-randomised, Open Feasibility Pilot for the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' (ReBOO) Trial
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReBOO
Brief Summary:
This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of the stomach. These injections will be repeated every six months.
The study sample will be adolescents with obesity who have not responded to standard conservative treatment.
The study sample will be adolescents with obesity who have not responded to standard conservative treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-000326-19 | EUDRACT_NUMBER | None | View |