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

Prospective, Multicenter, Clinical Trial to Evaluate the Safety of the STELLA® Endogastric Balloon at 7 Months and the Balloon Introduction System

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.

Study Overview

• Status: Completed
• Conditions: Overweight/Obesity
• Intervention / Treatment: Device: Balloon placement and inflation and removal of the Balloon

Detailed Description

The STELLA® endogastric balloon is a temporary, non-surgical implantable medical device designed to facilitate weight loss. It is made up of an endogastric balloon and a double-lumen probe or introducer system that allows the STELLA balloon to be placed inside the stomach. It works by partially filling the stomach, remaining freely inside, and stimulating a feeling of satiety, consequently reducing food intake.

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitario Dexeus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
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:

1. Patients who are participating or have participated in another clinical trial within the previous 30 days.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients treated with endogastric balloon STELLA in weight loss	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mikromic Medical, S. L
• Investigators: Principal Investigator: Eduard Espinet Coll, MD, Digestive and Bariatric Endoscopy Unit, Hospital Universitario Dexeus

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Endoscopy; gastroscopy; Intragastric balloon; STELLA
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: STELLA 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No