Overweight/ObesityNCT06744829
STELLA® Endogastric Balloon System. Evaluation of Safety and Introduction System at 7 Months.
A study testing Balloon placement and inflation and removal of the Balloon in people with Overweight/Obesity, run by Mikromic Medical, S. L at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight/Obesity
- What is being tested?
- Balloon placement and inflation and removal of the Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Patients with psychological or psychiatric disorders that, in the opinion of the psychologist, contraindicate their inclusion.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight/Obesity
- Being tested
- Balloon placement and inflation and removal of the Balloon
- Keywords
- STELLA, Intragastric balloon, gastroscopy, Obesity, Overweight, Endoscopy
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon placement and inflation and removal of the BalloonDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with endogastric balloon STELLA in weight loss | Experimental | Not described Receives: Device: Balloon placement and inflation and removal of the Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: Patient assessment over 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Apr 2022
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight/ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikromic Medical, S. L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduard Espinet Coll, MD, Principal investigator, Digestive and Bariatric Endoscopy Unit, Hospital Universitario Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744829
- Sponsor's protocol ID
- STELLA 2021
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40968297
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Clinical Trial to Evaluate the Safety of the STELLA® Endogastric Balloon at 7 Months and the Balloon Introduction System
- ClinicalTrials.gov ID
- NCT06744829
- Acronym / sponsor ID
- STELLA 2021
- Conditions
- Overweight/Obesity
- Keywords
- STELLA, Intragastric balloon, gastroscopy, Obesity, Overweight, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mikromic Medical, S. LIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with endogastric balloon STELLA in weight loss | Experimental | Device: Balloon placement and inflation and removal of the Balloon |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon placement and inflation and removal of the BalloonSTELLA 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 | Device | Patients treated with endogastric balloon STELLA in weight loss |
Primary outcome
Lack of occurrence of a Severe AE related to the use of the medical device under investigation during the intervention
Time frame: Patient assessment over 7 months
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%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 40968297Espinet-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Espinet Coll, MD principal investigator
Digestive and Bariatric Endoscopy Unit, Hospital Universitario Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon placement and inflation and removal of the Balloon in people with Overweight/Obesity, run by Mikromic Medical, S. L at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of occurrence of a Severe AE related to the use of the medical device under investigation during the intervention (time frame: Patient assessment over 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06744829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.