ArticleObesity science & practice2019
Safety, tolerability and efficacy of a novel self-use biodegradable device for management of obesity.
Article in Obesity science & practice, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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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.
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Who cites it
14 citing papers in PubMed, 25 citations in OpenAlex.
- Association of the Early Response to an Oral Shape-Shifting Superabsorbent Hydrogel Capsule With Weight Loss.Clinical obesity · 2026Trial
- Quality of life improvements associated with weight loss using a novel shape-shifting hydrogel capsule: RESET study results.International journal of obesity (2005) · 2026Trial
- Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study.Obesity (Silver Spring, Md.) · 2025Trial
- Non-Systemic Oral Cellulose-Based Superabsorbent Hydrogels for Weight Management: Potential Drug-Device Interactions Estimated by a Simplified In Vitro Assay.Pharmaceutics · 2026Article
- The safety and efficacy of extended use of an oral shape-shifting superabsorbent hydrogel capsule for weight loss: The ELECT extension study.Obesity pillars · 2025Article
- Preoperative weight loss by noninvasive approach in patients with obesity scheduled for bariatric and metabolic surgery: an update narrative review of indications and results available until 2024.Updates in surgery · 2025Review
- Weight and cardiometabolic effects of a novel oral shape-shifting superabsorbent hydrogel capsule: Prespecified and exploratory analysis of the Epitomee capsule RESET study.Obesity pillars · 2025Article
- Effects of an oral biodegradable device used for 12 weeks on weight reduction, cardiovascular risk factors, satiety, snacking, and meal size.Obesity pillars · 2023Article
- Diagnostic challenge: A pediatric patient with severe obesity and complications of imminent death.Obesity pillars · 2023Article
- Progress in the study of intragastric occupancy device for weight reduction.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2023Article
- Anti-Obesity Medications and Investigational Agents: An Obesity Medicine Association (OMA) Clinical Practice Statement (CPS) 2022.Obesity pillars · 2022Article
- Recent advances in therapies utilizing superabsorbent hydrogel technology for weight management: A review.Obesity science & practice · 2022Review
- Safety, tolerability and efficacy of a novel self-use biodegradable device for management of obesity.Obesity science & practice · 2019Article
- Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveObesity is a major public health issue with significant impact on quality of life, morbidity and mortality rates. It is estimated that if the current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. All the current therapies are not optimal due to limited efficacy or safety; thus, there is a need for additional devices for the treatment of obesity. This study aimed to examine the safety, tolerability, and efficacy of a biodegradable encapsulated Epitomee device for weight loss. The technology is based on absorbent pharmaceuticals polymers and bonding materials that self-expand in the stomach to create a pH-sensitive super absorbent gel structure for weight loss.
methodsA prospective, 12-week twice daily use of the encapsulated device in patients with body mass index of 27-40 kg m
resultsOverall, 52 patients completed the study. TBWL per intension-to-treat analysis was 3.68 ± 3.07% (3.23 ± 2.69 kg) and 4.52 ± 2.97% (3.95 ± 2.57 kg) per protocol. No device serious adverse effects reported. The most common adverse events were headache (18.1%), viral infection (11.5%), abdominal discomfort (10.1%), bloating (7.9%), nausea and constipation (5% each) and flatulence (4.3%). Endoscopy in 26 patients revealed mild, asymptomatic gastric/duodenal erythema without erosions in five patients.
conclusionsTwelve weeks of Epitomee capsules treatment combined with lifestyle counselling resulted in 3.68-4.52% of TBWL. With continued research, the Epitomee capsules have considerable potential to become a non-invasive, safe and effective treatment option for weight loss.
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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 OpenQuestion graph.