Evidence map›Paper›PMID 26253980›Full record

ArticleObesity surgery2016

Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study.

Evzen Machytka, Ram Chuttani, Martina Bojkova, Tomas Kupka, Marek Buzga, Kathryn Stecco, Samuel Levy, Shantanu Gaur

Abstract read
PubMed Publisher
In one paragraph

Article in Obesity surgery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Endoscopic bariatrics: Current status and emerging technologies.World journal of gastrointestinal endoscopy · 2025
    Review
  9. Article
  10. Article
  11. Article
  12. Overview on the endoscopic treatment for obesity: A review.World journal of gastroenterology · 2023
    Review
  13. Review
  14. Six intragastric balloons: Which to choose?World journal of gastrointestinal endoscopy · 2021
    Review
  15. Article
  16. Article
  17. Article
  18. Ultrasound-guided insertion of the ElipseJournal of ultrasound · 2020
    Article
  19. [Intragastric balloon for weight reduction: rationale, benefits, risks and indications].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2020
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Evzen MachytkaInternal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic. evmac@seznam.cz.
Ram ChuttaniDepartment of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. rchuttan@bidmc.harvard.edu.
Martina BojkovaInternal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic. martina.jelsikova@seznam.cz.
Tomas KupkaInternal Clinic, Department of Gastroenterology, University Hospital Ostrava, Ostrava, Czech Republic. tomas_kupka@post.cz.
Marek BuzgaFaculty of Medicine, University of Ostrava, 17. Listopadu 1790, Ostrava, 70800, Czech Republic. marek.buzga@osu.cz.
Kathryn SteccoAllurion Technologies, Wellesley, MA, USA. kathysteccomd@gmail.com.
Samuel LevyAllurion Technologies, Wellesley, MA, USA. slevy@allurion.com.
Shantanu GaurAllurion Technologies, Wellesley, MA, USA. sgaur@allurion.com.
University Hospital Ostrava · CZUniversity of Ostrava · CZHarvard University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse™, a procedureless gastric balloon.

methodsEight patients (mean BMI = 31.0 kg/m(2)) participated in this study. Each patient swallowed one Elipse™ balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed.

resultsAll eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities.

conclusionsThis pilot study demonstrates the safety and performance of Elipse™, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

Indexed as

AdultFemaleGastric BalloonHumansMaleMiddle AgedNauseaObesityPilot ProjectsTreatment OutcomeVomitingWeight LossYoung AdultGastric balloonIntragastric balloonObesityOverweightWeight loss

Identifiers

PMID26253980
OpenAlexW2185149368

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.