ENDOPLY System in Humans: a Pilot Study
NCT06292728 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-02-25
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
Conditions
Interventions
- DEVICE
-
ENDOPLY System
One endoscopic procedure where the ENDOPLY System is used for endoscopic gastric plication.
Sponsors & Collaborators
-
Just 4 Device s.r.o.
collaborator UNKNOWN -
ENDOPLY
lead OTHER
Principal Investigators
-
Jerome Dargent, MD · CEO, chief executive
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-09
- Primary Completion
- 2025-10-31
- Completion
- 2025-12-31
Countries
- Czechia
Study Locations
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