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

NCT06744829 | Completed

• 1 other identifier: STELLA 2021
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight/Obesity

Keywords

STELLA; Intragastric balloon; gastroscopy; Obesity; Overweight; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Lack of occurrence of a Severe AE related to the use of the medical device under investigation during the intervention

  Evaluate the efficacy of the STELLA® endogastric balloon on weight loss at 3 and 6 months (%TBWL, %EWL, % of patient with TBWL 10% and % of patient with EWL 25%)

  Patient assessment over 7 months

Study Arms (1)

Patients treated with endogastric balloon STELLA in weight loss

EXPERIMENTAL

Device: Balloon placement and inflation and removal of the Balloon

Interventions

Balloon placement and inflation and removal of the Balloon DEVICE

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

Patients treated with endogastric balloon STELLA in weight loss

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are overweight or obese, men and women, between 18 and 65 years of age, who have failed with previous diets and who require a physical aid that increases the sensation of satiety to reduce the amount of intake and thus promote weight loss.
• 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).
• 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.
• Morbidly obese subjects (BMI ≥40 kg/m²) requiring weight loss by endogastric balloon prior to bariatric surgery.
• Subjects who freely give written consent.
• 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.

You may not qualify if:

• Patients who are participating or have participated in another clinical trial within the previous 30 days.
• 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.
• Systemic diseases that prevent correct monitoring.
• Patients who do not give written informed consent to participate in the study.
• Pregnancy and breastfeeding.
• Unfavourable social-familial environment.
• Patients who have previously had an endogastric balloon placed, even if it has been successful, and request the prescription of a second balloon.
• Patients undergoing pharmacological treatment with anticoagulants, antiplatelet agents and/or NSAIDs.
• Patients with previous surgery, bariatric or gastrointestinal surgery.
• Previous esophageal or gastric surgery.
• Patients with large hiatal hernia.
• 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.
• Anatomical alterations: digestive stenosis or occlusion.
• Allergy to any of the implantable components.
• Hormonal, endocrine or genetic causes of obesity.

Sponsors & Collaborators

• Mikromic Medical, S. L: lead

Study Sites (1)

Hospital Universitario Dexeus

Barcelona, 08028, Spain

Location

Related Publications (1)

• 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.

  PMID: 40968297 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduard Espinet Coll, MD

  Digestive and Bariatric Endoscopy Unit, Hospital Universitario Dexeus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: April 1, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

ES (1)