Type 2 DiabetesNCT03072901
Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity
An observational study of Type 2 Diabetes and Obesity, run by Morphic Medical Inc..
Trial summary
The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- EndoBarrier Gastrointestinal Liner
- Type of treatment
- Medical device
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Feb 2016
- How long will I take part?
- 12 Months
- 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: The registry was open to subjects who met the EndoBarrier's Indications for Use, inclusion/exclusion criteria and contraindications in the device's Instructions For Use at the time the Registry was initiated.
Who may be able to join
- As per IFU, the EndoBarrier GI liner System is used for the treatment of obese type 2 diabetes with BMI greater than or equal to 30 kg/m2, or obese patients with BMI greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with BMI greater than 35 kg/m2. The GI liner is indicated for a maximum implant duration of 12 months.
Who cannot join
- As per Instructions For Use (IFU)
- Women who are pregnant
- Requirement for prescription anticoagulation therapy
- History of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (PUD), ulcers, or Crohn's disease
- Pancreatitis, Uncontrolled gastroesophageal reflux disease (GERD), Known infection at the time of implant
- Symptomatic coronary artery disease or pulmonary dysfunction
Show all 15Show fewer
- History of coagulopathy
- Bleeding diathesis, upper GI bleeding conditions such as esophageal or gastric varices, or congenital or acquired intestinal telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenosis
- Previous GI surgery that could affect the ability to place the EndoBarrier Gastrointestinal Liner or its function
- Iron deficiency and/or iron deficiency anemia
- Active symptoms of kidney stones or known presence of gallstones
- Inability to discontinue use of non-steroidal anti-inflammatory drugs during the implant period
- Family or patient history of known diagnosis or pre-existing condition of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder
- H. pylori positive status (Patients may receive the EndoBarrier Gastrointestinal Liner if they had a prior history and were successfully treated)
About this study
The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.
Read the detailed description
This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- EndoBarrier Gastrointestinal Liner
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrier Gastrointestinal LinerDevice
The EndoBarrier Gastrointestinal Liner (EndoBarrier) is a nonsurgical metabolic intervention for the treatment of Type 2 diabetes and obesity. By bypassing the duodenum and proximal jejunum, the device may alter signaling pathways that control metabolic processes.1, 2 The effect on patient's glucose levels is immediate as evidenced by meal tolerance testing.3 Since the device also promotes reduced appetite resulting in weight loss, the effect is maintained as the patient loses weight over the implant period. Most patients achieve normal HbA1c and fasting plasma glucose (FPG) levels rapidly within 3-6 months.
| Study group | Role | What they receive |
|---|---|---|
| EndoBarrier Gastrointestinal Liner | 244 subjects; The registry will be open to subjects who meet the EndoBarrier's Indications for Use and none of the Contraindications in the device's Instructions For Use document. Subjects who successfully receive the device implant at a participating registry center will be included in the registry. Receives: Device: EndoBarrier Gastrointestinal Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: 24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control
Change in %HbA1c from Baseline
Measured: Change from Baseline measured up to 24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss
Change from Baseline of weight (kg)
Measured: Change from Baseline measured up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startDec 2010
- Primary completionDec 2015
- Study completionFeb 2016
Why it stopped: GID terminated the Registry due to evolving registry requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 244 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Gersin, MD, Study director, GI Dynamics, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072901
- Sponsor's protocol ID
- 10-3
- Status last verified
- Mar 2017
- First submitted
- 19 Jan 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity
- ClinicalTrials.gov ID
- NCT03072901
- Acronym / sponsor ID
- 10-3
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: GID terminated the Registry due to evolving registry requirements
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Mar 2017 (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 purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.
Detailed description
This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoBarrier Gastrointestinal Liner | – | Device: EndoBarrier Gastrointestinal Liner244 subjects; The registry will be open to subjects who meet the EndoBarrier's Indications for Use and none of the Contraindications in the device's Instructions For Use document. Subjects who successfully receive the device implant at a participating registry center will be included in the registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry was open to subjects who met the EndoBarrier's Indications for Use, inclusion/exclusion criteria and contraindications in the device's Instructions For Use at the time the Registry was initiated.
Key inclusion criteria (1 listed)
- As per IFU, the EndoBarrier GI liner System is used for the treatment of obese type 2 diabetes with BMI greater than or equal to 30 kg/m2, or obese patients with BMI greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with BMI greater than 35 kg/m2. The GI liner is indicated for a maximum implant duration of 12 months.
Key exclusion criteria (15 listed)
- As per Instructions For Use (IFU)
- Women who are pregnant
- Requirement for prescription anticoagulation therapy
- History of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (PUD), ulcers, or Crohn's disease
- Pancreatitis, Uncontrolled gastroesophageal reflux disease (GERD), Known infection at the time of implant
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 |
|---|---|---|
| EndoBarrier Gastrointestinal LinerThe EndoBarrier Gastrointestinal Liner (EndoBarrier) is a nonsurgical metabolic intervention for the treatment of Type 2 diabetes and obesity. By bypassing the duodenum and proximal jejunum, the device may alter signaling pathways that control metabolic processes.1, 2 The effect on patient's glucose levels is immediate as evidenced by meal tolerance testing.3 Since the device also promotes reduced appetite resulting in weight loss, the effect is maintained as the patient loses weight over the implant period. Most patients achieve normal HbA1c and fasting plasma glucose (FPG) levels rapidly within 3-6 months. | Device | EndoBarrier Gastrointestinal Liner |
Primary outcome
Incidence of Adverse Events
Time frame: 24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control
Time frame: Change from Baseline measured up to 24 months
Change in %HbA1c from Baseline
Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss
Time frame: Change from Baseline measured up to 24 months
Change from Baseline of weight (kg)
Results and safety
The study was stopped early (reason given: GID terminated the Registry due to evolving registry requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- 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.
Keith Gersin, MD study director
GI Dynamics, Medical Director
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Obesity, run by Morphic Medical Inc..
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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: GID terminated the Registry due to evolving registry requirements). 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?
Incidence of Adverse Events (time frame: 24 months). The study lists 3 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 7 Mar 2017.