ENDOPLY System in Humans: a Pilot Study
Safety and Feasibility of the ENDOPLY System in Humans: a Pilot Study
1 other identifier
interventional
10
1 country
1
Brief Summary
Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jan 2022
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2022
CompletedFirst Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 25, 2025
February 1, 2025
3.7 years
February 15, 2024
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Time of duration of the ENDOPLY System study procedure
Median range of duration of the ENDOPLY System study procedure (hours).
Day 1 - Study Procedure
Number of ligatures placed by ENDOPLY System study procedure
Mean number of ligatures placed by ENDOPLY System study procedure (mean absolute value)
Day 1 - Study Procedure
Gastric perforation events
Number of adverse events related to gastric perforation events (absolute value)
12 months
Gastrointestinal bleeding events
Number of adverse event related to gastrointestinal bleeding events (absolute value)
12 months
Initial weight-loss
Mean weight loss at timepoints: initial assessment and at 1, 3, 6, 12 months (absolute value of mean weight reduction)
12 months
Study Arms (1)
Treatment
EXPERIMENTALInterventions
One endoscopic procedure where the ENDOPLY System is used for endoscopic gastric plication.
Eligibility Criteria
You may qualify if:
- BMI 30-40, i.e. class I and II obese patients
- Age above 18 and below 60 years
- Having failed multiples diet attempts
You may not qualify if:
- Achalasia and other oesophageal motility disorders
- Severe esophagitis
- Gastroduodenal ulcer
- Heart disease and hypertension without treatment
- Pulmonary, renal or hepatic failure, cancer
- Pregnancy ongoing, scheduled or in the past months
- Previous bariatric surgery or endoscopic bariatric technique
- Participation to another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ENDOPLYlead
- Just 4 Device s.r.o.collaborator
Study Sites (1)
Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení
Brno, 60200, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jerome Dargent, MD
CEO, chief executive
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2024
First Posted
March 5, 2024
Study Start
January 9, 2022
Primary Completion
October 1, 2025
Study Completion
December 1, 2025
Last Updated
February 25, 2025
Record last verified: 2025-02