George Woodman

The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity

BACKGROUND Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. OBJECTIVE To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. SETTING Academic and community practice, United States. METHODS Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. RESULTS Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). CONCLUSION The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial

Evaluate safety and efficacy of the pose™ procedure for obesity treatment.

Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study.

The effects of intragastric balloon (IGB) therapy on gastric emptying (GE) and weight loss remain to be fully understood. The effects of IGB on GE were investigated in this study.

Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial

Background/objectives:This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.Subjects/methods:In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30–40 kg m−2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.Results:At 6 months, weight loss was −3.3% of total body weight (−3.2 kg) in the lifestyle arm vs −10.2% (−9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was −3.4% (−3.2 kg) vs −9.1% (−8.8 kg, P⩽0.001); and at 12 months, −3.1% (−2.9 kg) vs −7.6% (−7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.Conclusions and relevance:Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss

BACKGROUND Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING Fifteen academic and private practice centers in the United States. METHODS This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.