ObesityNCT02954003
The ValenTx Endo Bypass System in Obese Subjects
A study testing Endo Bypass System in people with Obesity, run by ValenTx, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Endo Bypass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2013to Oct 2018
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18- 60 years old.
- BMI of 40-50 kg/m2 with or without comorbidities, BMI of 35-40 kg/m2 with one or more obesity related comorbidities, or BMI of 30-35 with type 2 diabetes
- Willing to give informed consent, and able to understand what this means.
- Documented failure with non-surgical weight loss methods.
- Willing to follow the study procedures and comply with the visits schedule.
- Live within a reasonable distance of the research center and be able to attend routine follow up visits.
Who cannot join
- Pregnancy or intention to become pregnant during the course of the study.
- Abnormal screening esophagogastroduodenoscopy findings
- Prior esophageal, gastric or bariatric surgery.
- Known allergies to any of the device materials.
- Use of weight loss drugs, stimulants and/or herbal weight loss supplements.
- Recent or ongoing health conditions that contraindicate undergoing an elective weight loss procedure involving a device implanted within the lumen of the esophagus, stomach and proximal small intestine.
- Participation in another clinical trial within 60 days of the implant.
- Presence of psychiatric conditions that would impair the ability to provide informed consent or to comply with study procedures.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
St. Joseph Healthcare
Hamilton, Ontario, L8N 4A6
Hopital Laval (IUCPQ)
Québec, Quebec
About this study
Official title: An Open Label Trial of the Safety and Effectiveness of the ValenTx Endo Bypass System and Use of the Endoscopic Anchor Placement Device in Obese Subjects
The purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.
Read the detailed description
- Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months.
- Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year.
- Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire.
- All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant.
- Subject participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis based on the condition of the implanted device.
- Conditions
- Obesity
- Being tested
- Endo Bypass System
- Keywords
- Obesity, Weight Loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo Bypass SystemDevice
Also called ValenTx System
Subject is implanted with the device for up to 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Endo Bypass | Experimental | Subjects implanted with the investigational ValenTx Endo Bypass System Receives: Device: Endo Bypass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
The proportion of subjects affected by SADEs during the 12 months following their device implant.
Measured: 1 Year
Secondary outcomes (1)
Mean 12 Month Weight Loss in Kilograms
Mean reduction in bodyweight in kilograms from the pre-implant baseline visit to the 12 month post-implant follow-up visit.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ValenTx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland Maude-Griffin, Study director, ValenTx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954003
- Sponsor's protocol ID
- EN 2.3
- Status last verified
- Nov 2016
- First submitted
- 23 Sep 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial of the Safety and Effectiveness of the ValenTx Endo Bypass System and Use of the Endoscopic Anchor Placement Device in Obese Subjects
- ClinicalTrials.gov ID
- NCT02954003
- Acronym / sponsor ID
- EN 2.3
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ValenTx, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 3 Nov 2016 (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 purpose of this study is to collect clinical data to support the use of the ValenTx Endo Bypass System to improve weight loss and the resolution of comorbidities in obese subjects.
Detailed description
- Single-arm, non-randomized, open-label, multi-center trial conducted in up to 70 subjects to assess the safety and efficacy of the ValenTx Endo Bypass System over implant duration of up to 36 months.
- Body weight, adverse events and device function in implanted subjects will be monitored at monthly visits for the first year after implant, at quarterly visits during the second year, and biannually during the third year.
- Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic assessments of the condition of the implanted device, and a quality of life questionnaire.
- All subjects will be followed for 12 months after device removal with scheduled visits at 1, 6 and 12 months after explant.
- Subject participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis based on the condition of the implanted device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endo Bypass | Experimental | Device: Endo Bypass SystemSubjects implanted with the investigational ValenTx Endo Bypass System |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18- 60 years old.
- BMI of 40-50 kg/m2 with or without comorbidities, BMI of 35-40 kg/m2 with one or more obesity related comorbidities, or BMI of 30-35 with type 2 diabetes
- Willing to give informed consent, and able to understand what this means.
- Documented failure with non-surgical weight loss methods.
- Willing to follow the study procedures and comply with the visits schedule.
Key exclusion criteria (8 listed)
- Pregnancy or intention to become pregnant during the course of the study.
- Abnormal screening esophagogastroduodenoscopy findings
- Prior esophageal, gastric or bariatric surgery.
- Known allergies to any of the device materials.
- Use of weight loss drugs, stimulants and/or herbal weight loss supplements.
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 |
|---|---|---|
| Endo Bypass SystemAlso: ValenTx SystemSubject is implanted with the device for up to 3 years. | Device | Endo Bypass |
Primary outcome
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
Time frame: 1 Year
The proportion of subjects affected by SADEs during the 12 months following their device implant.
1 secondary outcome
Mean 12 Month Weight Loss in Kilograms
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- 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.
Roland Maude-Griffin study director
ValenTx, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo Bypass System in people with Obesity, run by ValenTx, Inc. at 3 sites in 2 countries.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Mexico. 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?
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011. (time frame: 1 Year). 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 3 Nov 2016.