Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT00474318
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2007-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Adolescent Bariatrics: Assessing Health Benefits and Risk
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Organization:
Study Overview
Official Title:
Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Research Project
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Teen-LABS
Brief Summary:
The five Teen-LABS clinical centers use standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.
Detailed Description:
The goal of Teen-LABS is to facilitate coordinated clinical, epidemiological and behavioral research in the field of adolescent bariatric surgery, through the cooperative development of common clinical protocols and a bariatric surgery database that will collect information from participating clinical centers performing bariatric surgery on teenagers.
Teen-LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, shared clinical protocols and data collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care.
In addition to investigating surgical outcomes, another broader goal of Teen-LABS is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time.
In the 3rd five year cycle of funding for this project, several additional long-term research aims have been added, all in general alignment with the original aims of the project to assess efficacy and safety of bariatric surgery performed in adolescent years.
Teen-LABS will help pool the necessary clinical expertise and administrative resources to facilitate the conduct of multiple clinical studies in a timely, efficient manner. Also, the use of standardized definitions, shared clinical protocols and data collection instruments will enhance investigators' ability to provide meaningful evidence-based recommendations for patient evaluation, selection and follow-up care.
In addition to investigating surgical outcomes, another broader goal of Teen-LABS is to better understand the etiology, pathophysiology, and behavioral aspects of severe obesity in youth and how this condition affects human beings over time.
In the 3rd five year cycle of funding for this project, several additional long-term research aims have been added, all in general alignment with the original aims of the project to assess efficacy and safety of bariatric surgery performed in adolescent years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 7UM1DK072493-17 | NIH | None | https://reporter.nih.gov/quic… | View |
| 5UM1DK095710-10 | NIH | None | https://reporter.nih.gov/quic… | View |
| 5UM1DK072493-16 | NIH | None | https://reporter.nih.gov/quic… | View |