Diabetes Mellitus, Type 2NCT06256497
A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Fractyl Health Inc. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Duodenal Mucosal Resurfacing (DMR)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jun 2023to 1 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revita DMR Post Market Pilot Clinical Registry
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Duodenal Mucosal Resurfacing (DMR)
- Keywords
- Type 2 Diabetes, DMR, Duodenal Mucosal Resurfacing, Revita
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal Mucosal Resurfacing (DMR)Device
Also called Revita DMR
The Revita System is a hydrothermal ablation system, (CE) certified, intended to impart insulin-sensitizing properties to the body via ablation \& rejuvenation of the duodenal mucosa. As an adjunct to diet and exercise, Revita is intended to 1. improve glycemic control in patients with T2D who have preserved pancreatic beta cell function and whose diabetes is inadequately controlled despite oral and/or injectable glucose lowering medications and/or long-acting insulin therapy, 2. Reduce liver fat in patients with T2D and Non-Alcoholic Fatty Liver Disease (NAFLD). The single use Revita Catheter and Line Set are provided sterile and are not implantable or reusable. These disposables are used with the Revita Console an electromechanical device that controls the ablation cycle and submucosal expansion. The Revita System is used in a suitably equipped endoscopy suite. The Catheter contacts the patient's digestive tract for approximately 45-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| DMR Treated Patients | Not described Receives: Device: Duodenal Mucosal Resurfacing (DMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness
Improvement in glycemic control measured by fasting blood glucose (FPG)
Measured: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Improvement in glycemic control measured by HbA1c, random glucose (non-fasting),
Measured: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Improvement in glycemic control measured by fasting insulin
Measured: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Improvement in glycemic control measured by fasting plasma glucagon
Measured: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Improvement in glycemic control measured by C-peptide.
Measured: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Clinical effectiveness
Changes in antidiabetic medication dosages
Measured: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start27 Jun 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Why it stopped: The company paused enrollment due to a strategic decision to pause commercialization in the EU and specifically Germany. The company will follow currently enrolled subjects per protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fractyl Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Martin, MD, Principal investigator, Head of Diabetology and Director of the West-German Diabetology and Health Center (WDGZ)Jochen Seufert, MD, Study chair, Department Head Endocrinology and Diabetology, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256497
- Sponsor's protocol ID
- C-00075
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revita DMR Post Market Pilot Clinical Registry
- ClinicalTrials.gov ID
- NCT06256497
- Acronym / sponsor ID
- C-00075
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, DMR, Duodenal Mucosal Resurfacing, Revita
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The company paused enrollment due to a strategic decision to pause commercialization in the EU and specifically Germany. The company will follow currently enrolled subjects per protocol.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fractyl Health Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMR Treated Patients | – | Device: Duodenal Mucosal Resurfacing (DMR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duodenal Mucosal Resurfacing (DMR)Also: Revita DMRThe Revita System is a hydrothermal ablation system, (CE) certified, intended to impart insulin-sensitizing properties to the body via ablation \& rejuvenation of the duodenal mucosa. As an adjunct to diet and exercise, Revita is intended to 1. improve glycemic control in patients with T2D who have preserved pancreatic beta cell function and whose diabetes is inadequately controlled despite oral and/or injectable glucose lowering medications and/or long-acting insulin therapy, 2. Reduce liver fat in patients with T2D and Non-Alcoholic Fatty Liver Disease (NAFLD). The single use Revita Catheter and Line Set are provided sterile and are not implantable or reusable. These disposables are used with the Revita Console an electromechanical device that controls the ablation cycle and submucosal expansion. The Revita System is used in a suitably equipped endoscopy suite. The Catheter contacts the patient's digestive tract for approximately 45-60 minutes. | Device | DMR Treated Patients |
Primary outcome
Clinical effectiveness
Time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by fasting blood glucose (FPG)
Clinical effectiveness
Time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by HbA1c, random glucose (non-fasting),
Clinical effectiveness
Time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by fasting insulin
Clinical effectiveness
Time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by fasting plasma glucagon
Clinical effectiveness
Time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Improvement in glycemic control measured by C-peptide.
Clinical effectiveness
Time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.
Changes in antidiabetic medication dosages
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Martin, MD principal investigator
Head of Diabetology and Director of the West-German Diabetology and Health Center (WDGZ)
Jochen Seufert, MD study chair
Department Head Endocrinology and Diabetology, University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Fractyl Health Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness (time frame: Baseline, 1, 3-, 6-, 12-, and 24-months post-procedure.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.