A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity
References (21)
- et al.
Double-blind controlled trial of the Garren-Edwards Gastric Bubble: an adjunctive treatment for exogenous obesity
Gastroenterology
(1988) - et al.
Intragastric balloons in comparison with standard therapy for obesity—a randomized double-blind trial
Mayo Clin Proc
(1987) - et al.
The Garren Gastric Bubble: an Rx for the morbidly obese
Endosc Rev
(1984) - Frank BB, Stern WR, Fisher AH. Survey of gastric bubble usage in the United States, physicians workshop on the gastric...
- et al.
Health implications of obesity. National Institutes of Health Consensus development Conference Statement
Ann Intern Med
(1985) Surgical therapy for obesity
N Engl J Med
(1983)- et al.
Jejunoileal bypass for morbid obesity: late followup in 100 cases
N Engl J Med
(1983) - et al.
Gastric bypass: analysis of weight loss and factors determining success
Surgery
(1981) - et al.
Randomized trial of diet and gastroplasty compared with diet alone in morbid obesity
N Engl J Med
(1984) intragastric prosthesis for management of obesity
World J Surg
(1982)
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Endoscopic Balloon Therapy
2021, Surgical Clinics of North AmericaEndoscopic Treatments for Obesity: The Good, the Bad, and the Ugly
2020, Endocrinology and Metabolism Clinics of North AmericaCitation Excerpt :This was an endoscopically placed, air-filled device. Unfortunately, it was poorly tolerated with numerous adverse events, including mucosal injury, and was eventually removed from the market when a randomized controlled trial failed to show any benefit compared with a sham insertion.21 More recently, 3 IGBs have been approved by the US Food and Drug Administration for the treatment of obesity.
Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies
2017, GastroenterologyCitation Excerpt :All the current IGBs share the common goal of overcoming the limitations of the first intragastric balloon approved in the US; the Garren-Edwards Bubble, a 220-mL IGB made from polyurethane in the shape of a cylinder and filled with air. It was approved for use in the United States by the FDA in 1985, but was removed from commercial use in 1988 because of serious complications and lack of effective weight loss.15–18 Outcomes from the clinical trials that led to FDA approval in the IGBs that are currently approved are described in Table 2.
Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action
2017, Clinical Gastroenterology and HepatologyCitation Excerpt :However, it was associated with multiple adverse events including gastric mucosal damage and small-bowel obstruction. A sham-controlled trial failed to show efficacy and the device was withdrawn from the market.52 In the following decades, several IGBs have shown safety and efficacy, with broad adoption internationally.
Intragastric Balloon for the Treatment of Morbid Obesity
2017, Metabolism and Pathophysiology of Bariatric Surgery: Nutrition, Procedures, Outcomes and Adverse EffectsEndoscopic Management
2016, Gastroenterology Clinics of North America