STELLA® Endogastric Balloon System. Evaluation of Safety and Introduction System at 7 Months.
NCT ID: NCT06744829
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
69 participants
INTERVENTIONAL
2022-04-01
2023-12-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The STELLA 2021 clinical trial was conducted in six Spanish centers and was designed as a multicentre, non-randomized, longitudinal case series clinical study to demonstrate the safety and efficacy of the STELLA® endogastric balloon.
All centers followed a common protocol. The overall aim of the study was to include a minimum of 69 patients and to collect data from these participants during the visits according to the scheduled plan.
The planned visits for this clinical investigation included baseline (comprising Screening, Baseline Visit, and Informed Consent), procedure, discharge, a telephone follow-up at 72 hours, a 10-day follow-up visit, a 3-month follow-up visit, a 6-month follow-up visit (removal of the balloon), a 7-month follow-up telephone visit, and any unscheduled visits (the investigating team could decide to conduct an unscheduled visit).
The clinical investigation included adult subjects (aged between 18 and 65 years) who were candidates for intragastric balloon placement as an aid in the treatment of their obesity. The total duration of the clinical investigation was expected to be 13 months. The end of the clinical investigation occurred when the last visit of the last enrolled subject was completed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients treated with endogastric balloon STELLA in weight loss
Balloon placement and inflation and removal of the Balloon
STELLA Endogastric ballon will be inserted into the stomach and inflated with sterile saline solution and will remain in place for 6 months. After which the device will be removed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Balloon placement and inflation and removal of the Balloon
STELLA Endogastric ballon will be inserted into the stomach and inflated with sterile saline solution and will remain in place for 6 months. After which the device will be removed
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects with overweight grade II (BMI between 27.00-29.99 kg/m²) and obesity grade I (BMI between 30.00-34.99 kg/m²).
3. Subjects with grade II obesity (BMI between 35.00-39.99 kg/m²) provided they do not have more than 3 major comorbidities associated with obesity.
4. Morbidly obese subjects (BMI ≥40 kg/m²) requiring weight loss by endogastric balloon prior to bariatric surgery.
5. Subjects who freely give written consent.
6. The Stella balloon is especially indicated for patients with abnormal structures of the esophagus, oropharynx or with reduced lumen size, diverticula, or other processes as long as they are benign and do not impede the passage of the endoscope.
Exclusion Criteria
2. Patients who, in the opinion of the principal investigator or any of the specialists of the multicenter team, are not able to follow the instructions or to comply well with the assigned dietary treatment.
3. Systemic diseases that prevent correct monitoring.
4. Patients who do not give written informed consent to participate in the study.
5. Pregnancy and breastfeeding.
6. Patients with psychological or psychiatric disorders that, in the opinion of the psychologist, contraindicate their inclusion.
7. Unfavourable social-familial environment.
8. Patients who have previously had an endogastric balloon placed, even if it has been successful, and request the prescription of a second balloon.
9. Patients undergoing pharmacological treatment with anticoagulants, antiplatelet agents and/or NSAIDs.
10. Patients with previous surgery, bariatric or gastrointestinal surgery.
11. Previous esophageal or gastric surgery.
12. Patients with large hiatal hernia.
13. Patients with active esophagogastric pathology: Inflammatory: severe esophagitis (Los Angeles C-D), eosinophilic esophagitis, gastric and/or duodenal ulcer, Crohn's disease. Vascular: potentially bleeding lesions (varicose veins, angiomas, angiectasias). Neoplasia.
14. Anatomical alterations: digestive stenosis or occlusion.
15. Allergy to any of the implantable components.
16. Hormonal, endocrine or genetic causes of obesity.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mikromic Medical, S. L
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eduard Espinet Coll, MD
Role: PRINCIPAL_INVESTIGATOR
Digestive and Bariatric Endoscopy Unit, Hospital Universitario Dexeus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Dexeus
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Espinet-Coll E, Turro-Arau R, Nebreda-Duran J, Abad-Belando R, MartinezNunez-Martinez O, Saenger F, Varas-Lorenzo M, Samaniego-Aquino FA, Diaz-Galan P, Ortega-Sabater A, Grau-Manrubia G, Lopez-Roldan G, Alberdi-Alonso JM, Galvao Neto M. Prospective, Multicenter Clinical Trial to Evaluate the Safety of the Stella(R) Intragastric Balloon at 7 Months and the Balloon Delivery System. Obes Surg. 2025 Oct;35(10):4440-4451. doi: 10.1007/s11695-025-08264-y. Epub 2025 Sep 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STELLA 2021
Identifier Type: -
Identifier Source: org_study_id