NCT01429194

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable obesity

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

September 2, 2011

Last Update Submit

June 15, 2015

Conditions

Obesity

Keywords

Weight LossTrans-oral Endoscopic ProcedureGastric Plication

Outcome Measures

Primary Outcomes (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)

    Enrollment through 24 months post-procedure.

Secondary Outcomes (7)

  • Percent excess weight loss

    Procedure through 24 months post-procedure

  • Total weight lost (kg) and percent weight lost

    Procedure through 24 months post-procedure

  • Change in Body Mass Index (BMI) and percent change in BMI

    Procedure through 24 months post-procedure

  • Change in waist circumference

    Procedure through 24 months post-procedure

  • Improvement in co-morbid disease(s)

    Enrollment through 24 months post-procedure

  • +2 more secondary outcomes

Study Arms (1)

ACE procedure

EXPERIMENTAL

ACE procedure for the treatment of obesity

Procedure: ACE Stapler

Interventions

ACE StaplerPROCEDURE

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.

ACE procedure

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Aleman / Programa de Unidades Bariátricas

Autonoma de Bueno Aires, CP 1118, Argentina

Location

Hospital Italiano de Mendoza / Clinica Quirugica S. A.

Mendoza, 290, Argentina

Location

University Institute of Cardiology and Pulmonary Medicine of Quebec

Québec, Quebec, G1V 4G5, Canada

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64234, Israel

Location

Amsterdam Medical Center

Amsterdam, 110AZ, Netherlands

Location

University Hospital Maastricht

Maastricht, 6202, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25085333DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Simon Biron, MD

    University Institute of Cardiology and Pulmonary Medicine of Quebec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 7, 2011

Study Start

April 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

CA(1)IL(1)NL(2)AR(2)