Trial reportObesity surgery2025
Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella® Intragastric Balloon at 7 Months and the Balloon Delivery System.
Trial report in Obesity surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06744829 (Prospective, Multicenter, Clinical Trial to Evaluate the Safety of the STELLA® Endogastric Balloon at 7 Months and the Balloon Introduction System), which is not on this map. Not yet cited in PubMed.
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.
Prospective, Multicenter, Clinical Trial to Evaluate the Safety of the STELLA® Endogastric Balloon at 7 Months and the Balloon Introduction System
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe intragastric balloon (IGB) is a well-established treatment for obesity. However, several models have been developed to optimize outcomes and procedural efficiency. The Stella®-IGB is a novel, double-lumen device, designed for guidewire-assisted placement to improve procedural safety and patient comfort.
methodsThis is a prospective, multicenter, longitudinal, non-randomized study aimed to demonstrate the safety and feasibility of the Stella®-IGB system. Balloon insertion, delivery system, 6-month permanence integrity, 7-month adverse events (AEs) according to Clavien-Dindo AGREE classification, intolerance rate, weight loss and metabolic improvement were investigated.
resultsSixty-nine patients (72.46% females), median age of 42.0 years (IQR 34, 52) and BMI of 33.5 kg/m
conclusionStella®-IGB uses a double-lumen probe and a guidewire for a more comfortable and safe placement procedure. No serious AEs were observed. Stella®-IGB could expand current indications to IGB placement for endoscopists-in-training and in case of pharyngo-esophageal anatomical alterations. CLINICAL TRIAL NUMBER: NCT06744829.
Indexed as
Identifiers
What OpenQuestion holds
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.