ObesityNCT01207804
Feasibility Trial of ValenTx Endo Bypass System
A study testing ValenTx Endo Bypass System in people with Obesity, run by ValenTx, Inc. at 1 site in Mexico.
Trial summary
The purpose of the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- ValenTx Endo Bypass System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2008to May 2009
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age
- >=35 kg/m2 and <= 50 kg/m2, with or without comorbid conditions(s).
- Documented failure with non-surgical weight loss methods
- Willing to comply with study procedures and visit schedule
- Willing and able to provide Informed Consent
Who cannot join
- Pregnancy or intention of becoming pregnant within the study duration.
- Endoscopic lesions such as important hiatal hernia, gastric or duodenal ulcer, atresias or stenosis, polyps of the stomach.
- Subject with potential upper gastrointestinal bleeding such as esophageal or gastric varices, Mallory-Weis syndrome or congenital or acquired intestinal telangiectasia.
- Past history of esophageal or gastric/GI surgery, obstruction, adhesive peritonitis, or large hiatal hernia (> 3 cm).
- IBS, unexplained intermittent vomiting, severe abdominal pain or chronic constipation within 60 days of study day 1
- Unexplained anaemia, Pancreatitis, Portal hypertension, Esophagitis or Barrett's esophagus, known gallstones or anomalies of the GI tract
Show all 18Show fewer
- Any bodily infections within 30 days of study day 1.
- Prolonged steroid use
- Hep C or HIV positive
- Known allergies to any of the device materials
- Use of weight loss medication or an investigational drug or device within 2 months prior to enrolment and throughout the study period.
- Recent or ongoing cancer, history of severe renal, hepatic, cardiovascular or pulmonary disease or transplants
- Inability to tolerate anti-inflammatory medications
- Evidence of psychiatric problems or dietary habits that would contraindicate study treatment;
- Active drug or alcohol addiction within 12 months of enrolment and throughout the study duration.
- Prior history of inflammatory diseases of the GI tract, (e.g., esophagitis, varices, gastric or duodenal ulceration, or Crohn's disease; congenital or acquired GI anomalies, e.g., bowel strictures)
- Ongoing treatment with anticoagulants, steroids, aspirin, NSAIDs, or other gastric irritants within 1 month prior to enrollment and throughout the study period.
- Participation in previous (within 60 days of study day 1) or ongoing clinical trial or current or past usage (within 60 days of study day 1) of investigation drug or device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Patients
The purpose of the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients.
Read the detailed description
This is a single center open label feasibility study to evaluate the safety, efficacy and performance of the ValenTx Endo Bypass system.
- Conditions
- Obesity
- Being tested
- ValenTx Endo Bypass System
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValenTx Endo Bypass SystemDevice
Also called ValenTx, Endo Bypass System, EBS
Patient is implanted with device and followed for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Not described Receives: Device: ValenTx Endo Bypass System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related adverse events
Measured: 12 weeks
Secondary outcomes (1)
Device performance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMay 2009
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ValenTx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roberto Rumbaut, MD, Principal investigator, Hospital San Jose Tec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207804
- Sponsor's protocol ID
- FIM
- Status last verified
- Mar 2016
- First submitted
- 21 Sep 2010
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Feasibility Trial of the Safety and Efficacy of the ValenTx Endo Bypass System in Obese Patients
- ClinicalTrials.gov ID
- NCT01207804
- Acronym / sponsor ID
- FIM
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ValenTx, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Sep 2010 (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 the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients.
Detailed description
This is a single center open label feasibility study to evaluate the safety, efficacy and performance of the ValenTx Endo Bypass system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: ValenTx Endo Bypass System |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female between 18 and 55 years of age
- >=35 kg/m2 and <= 50 kg/m2, with or without comorbid conditions(s).
- Documented failure with non-surgical weight loss methods
- Willing to comply with study procedures and visit schedule
- Willing and able to provide Informed Consent
Key exclusion criteria (18 listed)
- Pregnancy or intention of becoming pregnant within the study duration.
- Endoscopic lesions such as important hiatal hernia, gastric or duodenal ulcer, atresias or stenosis, polyps of the stomach.
- Subject with potential upper gastrointestinal bleeding such as esophageal or gastric varices, Mallory-Weis syndrome or congenital or acquired intestinal telangiectasia.
- Past history of esophageal or gastric/GI surgery, obstruction, adhesive peritonitis, or large hiatal hernia (> 3 cm).
- IBS, unexplained intermittent vomiting, severe abdominal pain or chronic constipation within 60 days of study day 1
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 |
|---|---|---|
| ValenTx Endo Bypass SystemAlso: ValenTx, Endo Bypass System, EBSPatient is implanted with device and followed for 12 weeks | Device | Device |
Primary outcome
Device-related adverse events
Time frame: 12 weeks
1 secondary outcome
Device performance
Time frame: 12 weeks
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 17 Mar 2016.
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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.
Roberto Rumbaut, MD principal investigator
Hospital San Jose Tec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ValenTx Endo Bypass System in people with Obesity, run by ValenTx, Inc. at 1 site in Mexico.
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 18 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 17 Mar 2016. 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 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?
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?
Device-related adverse events (time frame: 12 weeks). 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 17 Mar 2016.