Status:
COMPLETED
Endosleeve in Adolescents
Lead Sponsor:
King Saud University
Collaborating Sponsors:
New You Medical Center
Conditions:
Obesity, Childhood
Eligibility:
All Genders
10-21 years
Phase:
PHASE1
PHASE2
Brief Summary
In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.
Detailed Description
Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but eff...
Eligibility Criteria
Inclusion
- BMI that is \>120% of the 95th percentile for age and gender
- Written informed assent/consent, with concomitant parental consent for patients aged ≤17 years
Exclusion
- Age \<10 years
- Age \>21 years
- Presence of large hiatal hernia
- Previous gastric surgery
- Cognitive impairment
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03778697
Start Date
December 1 2017
End Date
May 4 2019
Last Update
May 7 2019
Active Locations (1)
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1
New You Medical Center
Riyadh, Central Region, Saudi Arabia, 11671