ObesityePassNCT02954016
The ePass Clinical Trial for the Treatment of Obese Subjects
A study testing ePass in people with Obesity, run by ValenTx, Inc. at 2 sites in 2 countries.
Trial summary
To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity. The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods. 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?
- ePass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2016to Mar 2022
- 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
- 18-60 years of age.
- BMI ≥ 35 and ≤ 50 kg/m2
- Documented failure with non-surgical weight loss methods
- Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight
Who cannot join
- Pregnancy or intention of becoming pregnant.
- Past history of esophageal, gastric or bariatric surgery.
- Medical conditions contraindicating elective endoscopic or bariatric procedures.
- Insulin-dependent diabetes mellitus
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Argentina1 site
Hospital Italiano de Mendoza / Clinica Quiriurgica
Mendoza, 5500
About this study
Official title: Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial
To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.
The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.
Read the detailed description
- Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
- Subjects will be implanted with the EndoPass device for up to 36 months.
- Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
- Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
- All subjects will be followed for 12 months after device removal.
- A single device renewal may take place as needed after the initial implant.
- Subject study 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.
- Conditions
- Obesity
- Being tested
- ePass
- Keywords
- Obesity, Weight Loss, Hypertension, Type 2 Diabetes Mellitus, Hyperlipidemia
- Medical subject headings
- Obesity, Weight Loss, Hypertension, Diabetes Mellitus, Type 2, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePassDevice
Also called ValenTx, Endo Bypass System, EBS
Subject is implanted with the device for up to 3 years.
| Study group | Role | What they receive |
|---|---|---|
| ePass | Experimental | Subjects implanted with the investigational ValenTx Endo Bypass System Receives: Device: ePass |
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)
12 Month Weight Loss in Kilograms
Mean reduction in bodyweight in kilograms from the day of implant 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 startMar 2016
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (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
- 10 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
- NCT02954016
- Sponsor's protocol ID
- EP 1.0
- Acronym
- ePass
- 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
- Safety and Efficacy of the ValenTx EndoPass™ System for the Treatment of Obese Subjects: The ePass Clinical Trial
- ClinicalTrials.gov ID
- NCT02954016
- Acronym / sponsor ID
- ePass / EP 1.0
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss, Hypertension, Type 2 Diabetes Mellitus, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ValenTx, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (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.
To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity.
The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.
Detailed description
- Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites.
- Subjects will be implanted with the EndoPass device for up to 36 months.
- Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter.
- Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires.
- All subjects will be followed for 12 months after device removal.
- A single device renewal may take place as needed after the initial implant.
- Subject study 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ePass | Experimental | Device: ePassSubjects 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 (4 listed)
- 18-60 years of age.
- BMI ≥ 35 and ≤ 50 kg/m2
- Documented failure with non-surgical weight loss methods
- Self-reported maximum and minimum body weights during the past 12 months within 10% of current body weight
Key exclusion criteria (4 listed)
- Pregnancy or intention of becoming pregnant.
- Past history of esophageal, gastric or bariatric surgery.
- Medical conditions contraindicating elective endoscopic or bariatric procedures.
- Insulin-dependent diabetes mellitus
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 |
|---|---|---|
| ePassAlso: ValenTx, Endo Bypass System, EBSSubject is implanted with the device for up to 3 years. | Device | ePass |
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
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePass in people with Obesity, run by ValenTx, Inc. at 2 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 4 inclusion and 4 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 2 sites in Argentina, 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.