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ObesityNCT02381340

ACE Stapler Sub Study

An observational study of Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.

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

Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. 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 stapling procedure
How many people
10 participants
Where
1 siteNetherlands
Study dates
Jun 2012to Mar 2014
Phase
Observational
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

Study population: Patients that will undergo an ACE stapling procedure for the treatment of obesity.

Who may be able to join

  • Criteria for inclusion in main ACE stapling study:
  • 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, behaviour 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.
  • Patient must be included in the main study

Who cannot join

  • Main study
  • 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.
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  • 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.
  • 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.
  • Subject has renal and/or hepatic insufficiency.
  • Subject has thyroid disease which is not controlled with medication.
  • Subject has a history of intestinal strictures or adhesions.
  • Subject has systemic infection in the body at the time of the plication procedure.
  • Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
  • Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study.
  • Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
  • Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
  • Subject has chronic/acute upper GI bleeding conditions.
  • Subjects who are unable to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to a plication procedure and continuing for 14 days post-procedure.
  • Subjects undergoing chronic steroid therapy.
  • Subjects undergoing immunosuppressive therapy.
  • Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
  • Subjects who have started medications within the last 3 months that are known to cause weight gain.
  • Subjects who have cardiac pacemakers or other electronic implantable devices.
  • Subjects who have hiatal hernias greater than 2 cm.
  • Subjects who have current or potential neck masses that in the opinion of the investigator, may interfere with study-related procedures, or has a Mallampati (intubation) score greater than 3.
  • Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
  • Subject has Crohn's disease or Ulcerative Colitis.
  • Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
  • Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study.
  • Presence of contra-indications for MRI and f-MRI, as mentioned in Attachment 1 and 2.
  • Hypersensibility to contrast (Dotarem)
  • Claustrophobia
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, Limburg, 6202ZA

Other trials in Netherlands

About this study

Official title: Effect of the BaroSense ACE Stapler Procedure on Food Intake, Food Reward, Gastric Emptying, Hormone Release, Inflammatory Profile, Gut Microbiota and Behaviour Towards Food.

Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment options are limited and so far surgical intervention has been proven to be the only strategy to overcome severe obesity. However, bariatric surgery has limitations and risks, which might be minimized by non-incisional endoscopic procedures.

BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM) Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which intends to reduce the ability of the stomach to expand by creating plications in the region of the fundus and greater curvature. In contrast with other bariatric surgery it is endoscopically performed, reversible and if it fails most future surgical options are still open.

Read more

The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this plicating system for patients with severe obesity.

In this sub-study the investogators want to unravel the exact mechanism and provide more information about the efficacy of the BaroSense ACE™ Stapler. Therefore the authors will measure changes in various parameters that are known to affect weight loss and metabolism, before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters will only be measured in patients at MUMC+). These parameters are post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, satiety hormone release, microbiota composition and inflammatory markers.

Objectives:

Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, hormone release, microbiota composition and inflammatory markers.

Conditions
Obesity
Being tested
ACE stapling procedure
Keywords
Obesity, Bariatric surgery, Gastric plication, Minimal invasive surgery, gastrointestinal hormones, food-reward, satiety, microbiota
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACE stapling procedureDevice

    Endoscopic trans-oral gastroplication

What is being measured

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

  1. Satiety, food intake and hunger

    This will be evaluated in a test day before, 1 month after and 12 months after the procedure

    Measured: 1 year

Secondary outcomes (4)

  1. Changes in gastrointestinal hormone release

    GLP-1, PYY and ghrelin

    Measured: 1 year

  2. Gastric emptying

    Evaluated with 13C octanoic acid breath test and real-time MRI

    Measured: 1 year

  3. Behavior towards food and brain-related signaling

    Evaluated with fMRI, questionnaires (eating behavior) and computer tasks (liking, wanting)

    Measured: 1 year

  4. Inflammatory status

    By evaluating inflammatory plasma markers

    Measured: 1 year

Timeline

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

  1. First posted6 Mar 2015 (estimated)
  2. Study startJun 2012
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02381340
Sponsor's protocol ID
NL39402.068.12
Status last verified
Mar 2015
First submitted
2 Mar 2015
Last updated
12 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Paulus GF, van Avesaat M, Crijnen JAW, Ernest van Heurn LW, Westerterp-Plantenga MS, Bouvy ND. Preliminary evidence that endoscopic gastroplication reduces food reward. Appetite. 2020 Jul 1;150:104632. doi: 10.1016/j.appet.2020.104632. Epub 2020 Feb 15.

    PubMed 32070711

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.

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 10 inclusion and 35 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 12 Jan 2018. 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 Netherlands. 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?

Satiety, food intake and hunger (time frame: 1 year). 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 NCT02381340, 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 12 Jan 2018.

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ACE Stapler Sub Study (NCT02381340) | AzTrials