NOT_YET_RECRUITING
Effectiveness Gastric Balloon in Obese Adolescents
Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.
Conditions:
🦠 Obesity, Morbid
🗓️ Study Start (Actual) September 2024
🗓️ Primary Completion (Estimated) August 2026
✅ Study Completion (Estimated) August 2026
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Palo Alto, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI \> 3.5 SD)
    • * Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised
    • Exclusion Criteria
    • * Previous esophageal or gastric surgery or history of intestinal obstruction;
    • * History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
    • * Hiatus hernia \>5 cm or \<5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
    • * History of significant psychological disorder (permission sought from lead care giver).
Ages Eligible for Study: 14 Years to 19 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 December 2019
  • First Submitted that Met QC Criteria 20 December 2019
  • First Posted 24 December 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 December 2023
  • Last Update Posted 21 December 2023
  • Last Verified December 2023