Trial reportObesity surgery2013
A new endoscopically implantable device (SatiSphere) for treatment of obesity--efficacy, safety, and metabolic effects on glucose, insulin, and GLP-1 levels.
Trial report in Obesity surgery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 42 citations in OpenAlex.
- Endoscopic bariatrics: Current status and emerging technologies.World journal of gastrointestinal endoscopy · 2025Review
- Primary Bariatric Procedures.Digestive diseases and sciences · 2022Review
- Review
- Bariatric and Metabolic Therapies Targeting the Small Intestine.Techniques and innovations in gastrointestinal endoscopy · 2020Article
- The Role of Minimally Invasive and Endoscopic Technologies in Morbid Obesity Treatment: Review and Critical Appraisal of the Current Clinical Practice.Obesity surgery · 2020Review
- Endoscopic Interventions in the Treatment of Obesity and Diabetes.Digestive diseases and sciences · 2018Review
- Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2017Review
- Recent Trends in Endoscopic Bariatric Therapies.Clinical endoscopy · 2017Review
- A Novel Endoscopic Bariatric Procedure: Results of an Experimental Study.Obesity surgery · 2016Article
- Endoscopic Devices for Obesity.Current obesity reports · 2016Review
- Novel Endoscopic Management of Obesity.Clinical endoscopy · 2016Review
- Endoscopic therapy for weight loss: Gastroplasty, duodenal sleeves, intragastric balloons, and aspiration.World journal of gastrointestinal endoscopy · 2015Review
- Advances in the Endoscopic Management of Obesity.Gastroenterology research and practice · 2015Review
- Procedures and devices for bariatric and metabolic endoscopy.Therapeutic advances in gastrointestinal endoscopyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe endoluminal mechanical device SatiSphere is a new endoscopically implantable device designed to delay transit time of nutrients through the duodenum. It consists of a 1-mm nitinol wire with pigtail ends and several mesh spheres mounted along its course, released in the duodenum and gastric antrum to conform to the duodenal C loop configuration and thereby self-anchor.
methodsThe objective is to test the safety, efficacy, and effect on body weight in a 2:1 randomized study, as well as incretin secretion in a subgroup.
resultsOf 31 included cases (11 men, mean age 42.9 years, mean BMI 41.3 kg/m2), 21 patients treated with endoscopic device insertion with scheduled device removal after 3 months were compared with 10 controls. In 10 of 21 patients, device migration occurred, in two cases necessitating emergency surgery, which led to termination of the trial. Weight loss after 3 months was 6.7, 4.6, and 2.2 kg in the groups completing therapy, all treatment cases using intention to treat (ITT) analysis and controls. Excess weight loss was significantly increased by endoluminal mechanical device insertion (18.4, 12.2, and 4.4% in completers, ITT analysis group and controls; p = 0.02 for completers vs. controls). Measuring glucose, insulin, and glucagon-like peptide 1 (GLP-1) following a mixed-meal test with the device in place and after removal (n = 7), the device delayed glucose absorption and insulin secretion and altered kinetics in GLP-1 levels.
conclusionsThe device might be short-term effective in reducing body weight, which might be mediated through alterations in incretin metabolism. However, frequent device migration necessitates device modifications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.