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NCT06744829

STELLA® Endogastric Balloon System. Evaluation of Safety and Introduction System at 7 Months.

Completed NA Last updated 20 December 2024
What this trial tests

NA trial testing Balloon placement and inflation and removal of the Balloon in Overweight/Obesity in 69 participants. Completed in 5 December 2023.

Timeline
1 April 2022
Primary endpoint
5 December 2023
5 December 2023

Quick facts

Lead sponsorMikromic Medical, S. L
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment69
Start date1 April 2022
Primary completion5 December 2023
Estimated completion5 December 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Mikromic Medical, S. L

Who can join

Adults 18 to 65, any sex, with Overweight/Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of the study was to evaluate the safety of the introduction of STELLA® endogastric balloon and the endogastric balloon itself at 7 months. This investigation included screening visits and studies prior to placement, the endoscopic act of placement, the entire follow-up period while the balloon remains inside the stomach (6 months), the endoscopic act of balloon removal, as well as an additional follow-up after balloon removal of 1 month (7 months in total). Clinical, analytical and endoscopic parameters have also been evaluated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella® Intragastric Balloon at 7 Months and the Balloon Delivery System.
    Espinet-Coll E, Turró-Arau R, Nebreda-Durán J, Abad-Belando R, et al · · 2025 · PMID 40968297 · DOI 10.1007/s11695-025-08264-y

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Other recruiting trials for Overweight/Obesity

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06744829.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing