ObeseNCT01388673
Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy
A study testing BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy in people with Obese, run by BaroSense Inc..
Trial summary
The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese
- What is being tested?
- BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Feb 2013
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Subject, male or female, is age 18 to 60 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 must be > 2 years post RYGB surgery.
- Subject must have documented records indicating an initial achievement of > 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
- Subject has a BMI at baseline of > 30 and < 50.
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- At time of enrollment, subject must have regained at least 35% of the maximum weight lost following RYGB, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss.
- Subject must have a stoma diameter of at least 18 mm.
- Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
Who cannot join
- Subject has a severe eating disorder.
- Investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy.
- Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).
- Subject had irreversible or life threatening complications following initial RYGB procedure (cardio or respiratory).
- Subject has an ongoing severe complication from their initial RYGB procedure (recurrent ventral hernia, pain syndrome, etc.).
- Subject has an intragastric fistula, anastomotic leak, or staple/suture line disruption.
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- Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
- 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.
About this study
Official title: Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for Plication of Dilated Post-surgical Gastric Anatomy
The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. This study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass (RYGB) pouch.
The primary objective of this study is to perform an evaluation of the safety of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy.
The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.
- Conditions
- Obese
- Being tested
- BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy
- Keywords
- prior RYGB procedure, regained weight over time, dilated pouch and/or stoma
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomyProcedure or surgery
The ACE Stapler is used endoscopically, an incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.
| Study group | Role | What they receive |
|---|---|---|
| ACE Stapler procedure | Experimental | ACE Stapler procedure for the treatment of dilated post-surgical gastric anatomy Receives: Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with adverse events
The primary safety analysis will assess the occurrence of adverse events through 12 months following procedures. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 12 month follow-up evaluation: Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Measured: Post-procedure through 12 months
Secondary outcomes (1)
Percent excess weight loss in participants relative to preop weight
Efficacy measurements will be analyzed relative to the surgery visit. The collected measures will include:
- Percent Excess Weight Loss (%EWL) defined as: (preop weight-current weight)/ (preop weight - ideal weight) *100, where ideal weight is calculated from a BMI of 25 based on the subject's height.
- Total weight lost (kg)
- Change in body mass index (BMI)
- Change in waist circumference
- Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values
Measured: Through 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BaroSense Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388673
- Sponsor's protocol ID
- Protocol 11-02
- Status last verified
- Feb 2012
- First submitted
- 1 Jul 2011
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for Plication of Dilated Post-surgical Gastric Anatomy
- ClinicalTrials.gov ID
- NCT01388673
- Acronym / sponsor ID
- Protocol 11-02
- Conditions
- Obese
- Keywords
- prior RYGB procedure, regained weight over time, dilated pouch and/or stoma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BaroSense Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 7 Jul 2011 (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 Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. This study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass (RYGB) pouch.
The primary objective of this study is to perform an evaluation of the safety of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy.
The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACE Stapler procedure | Experimental | Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomyACE Stapler procedure for the treatment of dilated post-surgical gastric anatomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject, male or female, is age 18 to 60 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 must be > 2 years post RYGB surgery.
- Subject must have documented records indicating an initial achievement of > 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
Key exclusion criteria (9 listed)
- Subject has a severe eating disorder.
- Investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy.
- Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).
- Subject had irreversible or life threatening complications following initial RYGB procedure (cardio or respiratory).
- Subject has an ongoing severe complication from their initial RYGB procedure (recurrent ventral hernia, pain syndrome, etc.).
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 |
|---|---|---|
| BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomyThe ACE Stapler is used endoscopically, an incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach. | Procedure or surgery | ACE Stapler procedure |
Primary outcome
Proportion of participants with adverse events
Time frame: Post-procedure through 12 months
The primary safety analysis will assess the occurrence of adverse events through 12 months following procedures. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 12 month follow-up evaluation: Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
1 secondary outcome
Percent excess weight loss in participants relative to preop weight
Time frame: Through 12 months post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy in people with Obese, run by BaroSense 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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Feb 2012. 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 withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants with adverse events (time frame: Post-procedure through 12 months). 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 8 Feb 2012.