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

NCT06744829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-12-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Mikromic Medical, S. L

    lead INDUSTRY

Principal Investigators

  • Eduard Espinet Coll, MD · Digestive and Bariatric Endoscopy Unit, Hospital Universitario Dexeus

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-12-05
Completion
2023-12-05

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744829 on ClinicalTrials.gov