ObesityPhase 1NCT00707720
Multi-Center Feasibility Study of Trans-oral Endoscopic Restrictive Implant System (TERIS) for Treatment of Obesity
A Phase 1 study testing TERIS procedure in people with Obesity, run by BaroSense Inc. at 1 site in Canada.
Trial summary
The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational system being evaluated for safety The system uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- TERIS procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Dec 2011
- Phase
- Phase 1
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All of the following criteria must be met for study participation/device implantation:
- Subject, male or female, is age 18 to 50 years of age.
- Subject must be able to understand and be willing to sign an informed consent document.
- Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
- Subject has a BMI of 40.0-49.0 or has a BMI of 35.0-39.9 plus one or more co-morbid diseases expected to improve with weight loss (e.g. hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus).
- Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
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- Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
- Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
- Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination.
- Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial.
Who cannot join
- A subject is ineligible to participate in this study if they meet any of the following criteria:
- Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
- Subject has an A1C ≥ 7.0%, or other indicator of poorly controlled diabetes.
- Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility.
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- Subject has renal and/or hepatic insufficiency.
- Subject has thyroid disease which is not controlled with medication.
- Subject has a history of intestinal strictures or adhesions.
- Subject has systemic infection in the body at the time of TERIS procedure.
- Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device implant), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
- Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
- Subjects who are unable to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to a device implant or device removal procedure and continuing for 14 days post-procedure(s).
- Subjects undergoing chronic steroid therapy.
- Subjects undergoing immunosuppressive therapy.
- Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
- Subjects who have cardiac pacemakers or other electronic implantable devices.
- Subjects who have hiatal hernias greater than 2 cm.
- Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
- Subject has Crohn's disease or Ulcerative Colitis.
- Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
- Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within £ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Feasibility Study to Evaluate the Safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) for the Treatment of Obesity
The Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational system being evaluated for safety The system uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety. The Intended Use of the system is for the treatment of obesity.
Read the detailed description
Obesity is now considered to be epidemic through most of the industrialized world. The consequences of obesity on long-term health of individuals is now well documented. While lifestyle changes in diet and activity level are the key instruments to arresting or reversing this condition, conventional medically supervised programs have proven only marginally effective. Bariatric surgery has shown to be a reliable long-term treatment for reducing excess body weight. Though surgical techniques have evolved and complication rates have been reduced, surgery on these patients still carries significant mortality and morbidity.
Techniques and instruments are now being developed to allow for Endoscopic approaches to these procedures that will aim to reduce the complications associated with open or laparoscopic technique for these procedures.
The primary objective of this study is to evaluate the safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) procedure for the treatment of obesity over a six month follow-up period.
A secondary objective is to perform a preliminary evaluation of the efficacy of the TERIS procedure in order to guide the design of future studies, including a pivotal trial.
This is a prospective feasibility study at up to 3 investigational sites of up to 40 subjects who are obese and have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone, or in combination. Up to 60 subjects may be enrolled, and undergo baseline evaluation in order to obtain a final total of up to 40 subjects appropriate for trans-oral implant. Barosense intends to use data from this study in support of subsequent investigational studies, including a pivotal trial
- Conditions
- Obesity
- Being tested
- TERIS procedure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERIS procedureDevice
The implantation of the restrictive implant
| Study group | Role | What they receive |
|---|---|---|
| TERIS procedure | Experimental | TERIS procedure for the treatment of obesity Receives: Device: TERIS procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events relating to the procedure and device
Measured: 6 months
Secondary outcomes (1)
Weight loss, Excess weight loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BaroSense Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Stecco, MD, Study director, Medical Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707720
- Sponsor's protocol ID
- BSI 07-01
- Status last verified
- Apr 2013
- First submitted
- 27 Jun 2008
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Biertho L, Hould FS, Lebel S, Biron S. Transoral endoscopic restrictive implant system: a new endoscopic technique for the treatment of obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):203-5. doi: 10.1016/j.soard.2009.08.006. Epub 2009 Aug 28. No abstract available.
PubMed 19796996
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Feasibility Study to Evaluate the Safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT00707720
- Acronym / sponsor ID
- BSI 07-01
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BaroSense Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Jul 2008 (estimated)
- 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 Barosense Trans-oral Endoscopic Restrictive Implant System (TERIS) is an investigational system being evaluated for safety The system uses endoscopic guidance to trans-orally implant a restrictive reservoir for food entering the stomach in obese and morbidly obese subjects to induce early and prolonged satiety. The Intended Use of the system is for the treatment of obesity.
Detailed description
Obesity is now considered to be epidemic through most of the industrialized world. The consequences of obesity on long-term health of individuals is now well documented. While lifestyle changes in diet and activity level are the key instruments to arresting or reversing this condition, conventional medically supervised programs have proven only marginally effective. Bariatric surgery has shown to be a reliable long-term treatment for reducing excess body weight. Though surgical techniques have evolved and complication rates have been reduced, surgery on these patients still carries significant mortality and morbidity.
Techniques and instruments are now being developed to allow for Endoscopic approaches to these procedures that will aim to reduce the complications associated with open or laparoscopic technique for these procedures.
The primary objective of this study is to evaluate the safety of the Trans-oral Endoscopic Restrictive Implant System (TERIS) procedure for the treatment of obesity over a six month follow-up period.
A secondary objective is to perform a preliminary evaluation of the efficacy of the TERIS procedure in order to guide the design of future studies, including a pivotal trial.
This is a prospective feasibility study at up to 3 investigational sites of up to 40 subjects who are obese and have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone, or in combination. Up to 60 subjects may be enrolled, and undergo baseline evaluation in order to obtain a final total of up to 40 subjects appropriate for trans-oral implant. Barosense intends to use data from this study in support of subsequent investigational studies, including a pivotal trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TERIS procedure | Experimental | Device: TERIS procedureTERIS procedure for the treatment of obesity |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- All of the following criteria must be met for study participation/device implantation:
Key exclusion criteria (23 listed)
- A subject is ineligible to participate in this study if they meet any of the following criteria:
- Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
- Subject has an A1C ≥ 7.0%, or other indicator of poorly controlled diabetes.
- Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
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 |
|---|---|---|
| TERIS procedureThe implantation of the restrictive implant | Device | TERIS procedure |
Primary outcome
Adverse Events relating to the procedure and device
Time frame: 6 months
1 secondary outcome
Weight loss, Excess weight loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
- Derived from this study: PubMed 19796996Biertho L, Hould FS, Lebel S, Biron S. Transoral endoscopic restrictive implant system: a new endoscopic technique for the treatment of obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):203-5. doi: 10.1016/j.soard.2009.08.006. Epub 2009 Aug 28. No abstract available.
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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.
Kathy Stecco, MD study director
Medical Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TERIS procedure in people with Obesity, run by BaroSense Inc. at 1 site in Canada.
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 10 inclusion and 23 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: finished, as of the sponsor's last update on 10 Apr 2013. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events relating to the procedure and device (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707720, which also lists 1 linked publication.
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 10 Apr 2013.