Clinical trial NCT06256497: A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient With Type 2 Diabetes
Official title: Revita DMR Post Market Pilot Clinical Registry
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
DMR
Duodenal Mucosal Resurfacing
Revita
Lead sponsor: Fractyl Health Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes and meeting the study inclusion and exclusion criteria below. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.

Brief summary: The Revita DMR Post Market Pilot Clinical Registry is a post-market, prospective, observational, noninterventional clinical registry in patients with T2D in Germany undergoing the Revita Procedure with the CE marked Revita System (Fractyl Health, Lexington, MA, USA) in accordance with its intended purposes. Patient's participation in this study has no impact on his or her indication or opportunity to receive therapy. Patients are to be treated in compliance with the current Revita System's IFU of the CE marked Revita System as well as according to medical society guidelines and physician discretion.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent in accordance with GCP and local legislation
* Adults (≥18 years) with the diagnosis of T2D
* BMI of \<=45 kg/m2 at the time of presentation/screening
* T2D mellitus inadequately controlled on therapy (HbA1c ≥7.0 and ≤10.0% \[53-86 mmol/mol\] at the time of initial presentation for screening and with the need for therapy escalation \[dose increase of existing therapy or additional prescription of insulin and/or OADs or change of therapy regimen\]) to achieve the therapeutic HbA1c target defined by the physician
* Treatment with oral and/or injectable glucose lowering medications and/or long-acting insulin therapy

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical effectiveness
timeFrame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
measure: Clinical effectiveness
timeFrame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
measure: Clinical effectiveness
timeFrame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
measure: Clinical effectiveness
timeFrame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
measure: Clinical effectiveness
timeFrame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
measure: Clinical effectiveness
timeFrame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Westdeutsches Diabetes und Gesundheitszentrum
Study officials:
affiliation: Head of Diabetology and Director of the West-German Diabetology and Health Center (WDGZ)
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department Head Endocrinology and Diabetology, University Hospital Freiburg
name: Jochen Seufert, MD
role: STUDY_CHAIR
References: