Last reviewed · How we verify
NCT06744829
STELLA® Endogastric Balloon System. Evaluation of Safety and Introduction System at 7 Months.
NA trial testing Balloon placement and inflation and removal of the Balloon in Overweight/Obesity in 69 participants. Completed in 5 December 2023.
5 December 2023
Quick facts
| Lead sponsor | Mikromic Medical, S. L |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 69 |
| Start date | 1 April 2022 |
| Primary completion | 5 December 2023 |
| Estimated completion | 5 December 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Balloon placement and inflation and removal of the Balloon
Conditions studied
- Overweight/Obesity — all drugs for Overweight/Obesity →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06744829
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06744829 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mikromic Medical, S. L
- Last refreshed: 20 December 2024
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