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Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®

NCT06087822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2024-12-09

No results posted yet for this study

Summary

The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.

Conditions

  • Overweight or Obesity

Interventions

DEVICE

IMD SiPore21®

The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c

Sponsors & Collaborators

  • Sigrid Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Maria Klockare · Sigrid Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2024-07-30
Completion
2024-07-30

Countries

  • Poland
  • Romania
  • Slovakia

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 NCT06087822 on ClinicalTrials.gov