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ObesityNCT01429194

The ACE Follow-up Study

A study testing ACE Stapler in people with Obesity, run by Boston Scientific Corporation at 6 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obesity
What is being tested?
ACE Stapler
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
6 sitesin 4 countries
Study dates
Apr 2012to Feb 2015
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 - 45 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to 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.
  • Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
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  • 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, as assessed by an interview with a member of the study team at baseline.
  • 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

  • Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
  • Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years.
  • Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure.
  • Subject has a history or is diagnosed with eating disorders.
  • Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure.
  • Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
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  • 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.
  • Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed.

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Argentina2 sites

  • Hospital Aleman / Programa de Unidades Bariátricas

    Autonoma de Bueno Aires, CP 1118

  • Hospital Italiano de Mendoza / Clinica Quirugica S. A.

    Mendoza, 290

Other trials in Argentina

Netherlands2 sites

  • Amsterdam Medical Center

    Amsterdam, 110AZ

  • University Hospital Maastricht

    Maastricht, 6202

Other trials in Netherlands

Canada1 site

  • University Institute of Cardiology and Pulmonary Medicine of Quebec

    Québec, Quebec, G1V 4G5

Other trials in Canada

Israel1 site

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64234

Other trials in Israel

About this study

Official title: Continuation of Follow-up for Patients Who Were Previously Enrolled in the Clinical Study: "Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for the Treatment of Obesity - (Protocol 11-03)."

The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program.

The primary objective of this study is to perform an evaluation of the safety of the plication procedure.

The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period.

Read the detailed description

This study was originally sponsored by BaroSense, Inc (protocol 11-03). 69 subjects were enrolled and treated as part of the study at 6 centers in 4 countries outside the United States. On April 30, 2013 BaroSense Inc went out of business and the study was terminated with all participating centers' Ethics Committees. At the point of study termination, all patients were in the middle of post procedure follow-up.

Boston Scientific has since acquired the technology and study and will re-initiate follow-up to 24 months in order to collect data to support the original safety and efficacy endpoints of the protocol. Only the 69 subjects previously enrolled and treated in BaroSense's protocol 11-03 will be eligible for participation in the Boston Scientific continued follow-up study ("The ACE Follow-up Study" protocol 90891629). The Boston Scientific protocol will be approved by participating centers' Ethics Committees and patients who choose to participate in The ACE Follow-up Study will need to sign a new, Ethics Committee Approved, informed consent form.

Conditions
Obesity
Being tested
ACE Stapler
Keywords
Weight Loss, Trans-oral Endoscopic Procedure, Gastric Plication
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.

  • ACE StaplerProcedure or surgery

    The ACE Stapler is used endoscopically, and incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.

Study groups in NCT01429194
Study groupRoleWhat they receive
ACE procedureExperimentalACE procedure for the treatment of obesity
Receives: Procedure: ACE Stapler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    The primary safety analysis will assess the occurrence and procedure relatedness of the following events:

    • Adverse Events (AE)
    • Adverse Device Effects (ADE)
    • Serious Adverse Events (SAE)
    • Unanticipated Adverse Device Effects (UADE)

    Measured: Enrollment through 24 months post-procedure.

Secondary outcomes (7)

  1. Percent excess weight loss

    Percent excess weight loss (%EWL), defined as: (preoperative weight-current weight)/(preoperative weight - ideal weight) *100, where ideal weight is the weight that would correspond to a BMI of 25 based on the subject's height.

    Relative to weight at the procedure visit.

    Measured: Procedure through 24 months post-procedure

  2. Total weight lost (kg) and percent weight lost

    Relative to weight at the procedure visit.

    Measured: Procedure through 24 months post-procedure

  3. Change in Body Mass Index (BMI) and percent change in BMI

    Relative to BMI at the procedure visit.

    Measured: Procedure through 24 months post-procedure

  4. Change in waist circumference

    Relative to to waist circumference at the procedure visit.

    Measured: Procedure through 24 months post-procedure

  5. Improvement in co-morbid disease(s)

    Including but not limited to, improvement in vital signs and/or laboratory values.

    Measured: Enrollment through 24 months post-procedure

  6. Changes in Quality of Life

    As reported on the SF-36 Quality of LIfe Questionnaire.

    Measured: Enrollment through 24 months post-procedure

  7. Changes in Feelings of Satiety

    As reported on the TFEQ-R18 Three Factor Eating Questionnaire.

    Measured: Enrollment through 24 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01429194
Sponsor's protocol ID
90891629
Other IDs
90891629
Status last verified
Jun 2015
First submitted
2 Sep 2011
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Verlaan T, Paulus GF, Mathus-Vliegen EM, Veldhuyzen EA, Conchillo JM, Bouvy ND, Fockens P. Endoscopic gastric volume reduction with a novel articulating plication device is safe and effective in the treatment of obesity (with video). Gastrointest Endosc. 2015 Feb;81(2):312-20. doi: 10.1016/j.gie.2014.06.017. Epub 2014 Jul 29.

    PubMed 25085333

Questions about this trial

What is this clinical trial studying?

A study testing ACE Stapler in people with Obesity, run by Boston Scientific Corporation at 6 sites in 4 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 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: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Argentina, Netherlands, Canada, Israel. 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?

Safety (time frame: Enrollment through 24 months post-procedure.). 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 NCT01429194, 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 16 Jun 2015.

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The ACE Follow-up Study (NCT01429194) | AzTrials