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ObesityNCT01448785

Abiliti™ Treatment in Obese Subjects

A study testing abiliti system implant and Laparoscopic adjustable gastric band (Allergan Lap Band) in people with Obesity and Morbid Obesity, run by IntraPace, Inc at 15 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Morbid Obesity
What is being tested?
abiliti system implant and Laparoscopic adjustable gastric band (Allergan Lap Band)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
15 sitesin 6 countries
Study dates
Apr 2011to Jan 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age of 18 - 60 years old at time of screening
  • BMI of 40 to 55 or 35 to 39 with an obesity related comorbid condition at time of screening
  • History of obesity ≥5 years
  • The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
  • Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  • No significant weight loss (<5%) within four months prior to enrollment as documented in the subject's medical record.
Show all 12Show fewer
  • Successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment.
  • Glycosylated Hemoglobin; HbA1c ≤ 7.0 % at Visit 2 or historic value performed no more than 3 months prior to enrollment.
  • If taking anti-depressant medications, they must be stable for at least six months prior to enrollment
  • Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
  • Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
  • Able to provide voluntary informed consent

Who cannot join

  • Any prior bariatric surgery
  • Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
  • Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures
  • Use of anti-psychotic medications
  • Diagnosed with a eating disorder such as bulimia or binge eating
  • Obesity due to an endocrinopathy (e.g. Cushing disease)
Show all 19Show fewer
  • Insulin therapy
  • GI disease such as hiatal hernia (>5cm), gastroparesis, esophageal motility disorders or intractable constipation.
  • Cirrhosis, chronic pancreatitis
  • History of intestinal obstruction or adhesive peritonitis
  • Any history of peptic ulcer disease within 5 years prior to enrollment
  • Women who are pregnant, lactating or anticipate becoming pregnant within 24 months
  • Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study.
  • Chronic use of aspirin and/or non steroidal anti-inflammatory medications and unwillingness to discontinue use
  • Cardiac history that physician feels should exclude the patient from the study.
  • Concurrent use of weight loss medications.
  • Use of another investigational device or agent in the 30 days prior to enrollment
  • A history of life-threatening disease within 5 years prior to enrollment
  • Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study

Trial locations and contacts

15 sites in 6 countries.

Robert Nardelli contact

650-316-4065

15 sites in 6 countries

Germany5 sites, 4 recruiting

  • MIC Ev. Krankenhaus Hubertus

    Berlin, 14129

    Martin Susewind, MD

    Martin Susewind, MD

    Recruiting

  • SRH Wald-Klinikum Gera

    Gera, 07548

    Christine Stroh, MD

    Christine Stroh, MD

    Recruiting

  • Wolfart Klinik

    Gräfelfing, 92166

    Active, not recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Oliver Mann, MD

    Oliver Mann, MD

    Recruiting

  • Stadtkrankenhaus Schwabach

    Schwabach, 91126

    Thomas Horbach, MD

    Thomas Horbach, MD

    Recruiting

Other trials in Germany

Italy3 sites, 3 recruiting

  • Azienda Ospedaliera- University

    Pisa

    Marco Anselmino, MD

    Marco Anselmino, MD

    Not yet recruiting

  • Clinica San Luca Torino

    Turin

    Giuseppe M Rovera, MD

    Giuseppe M Rovera, MD

    Not yet recruiting

  • Vicenza Regional Hospital

    Vicenza, 36100

    Franco Favretti, MD

    Franco Favretti, MD

    Not yet recruiting

Other trials in Italy

United Kingdom3 sites, 3 recruiting

  • Mid Yorkshire NHS Trust

    Dewsbury, West Yorkshire, WF13 4HS

    Chinnadorai Rajeswaran, MD

    Chinnadorai Rajeswaran, MD

    Not yet recruiting

  • Spire Southampton Hospital

    Hampshire, Southampton, SO16 6UY

    James Byrne, MD

    James Byrne, MD

    Not yet recruiting

  • St. Anthony's Hospital

    North Cheam, Surrey, SM3 9DW

    Alberic Fiennes, MD

    Alberic Fiennes, MD

    Not yet recruiting

Other trials in United Kingdom

Spain2 sites, 2 recruiting

  • Complutense University of Madrid Hospital Clinico "San Carlos"

    Madrid, 28290

    Antonio J Torres, MD

    Antonio J Torres, MD

    Not yet recruiting

  • Hospital Virgen del Roció

    Seville, 41013

    Salvador Morales Conde, MD

    Salvador Morales Conde, MD

    Recruiting

Other trials in Spain

France1 site, 1 recruiting

  • Polyclinique de Rillieux, Clinique Lyon-Nord

    Rillieux Cedex, 69165

    Jerome Dargent, MD

    Jerome Dargent, MD

    Recruiting

Other trials in France

Switzerland1 site, 1 recruiting

  • Klinik Lindberg

    Winterthur, 8400

    Fritz Horber, MD

    Fritz Horber, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study

The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.

Read the detailed description

This study is intended to provide additional data regarding the performance and safety of the abiliti system in comparison to gastric banding. The composite end-point of the study is designed to provide a direct comparison of the effectiveness of the devices for the treatment of obesity while giving consideration to the safety profile for each device and their impact on patient quality of life.

Being tested
abiliti system implant, Laparoscopic adjustable gastric band (Allergan Lap Band)
Keywords
obesity, gastric stimulation, morbid obesity
Medical subject headings
Obesity, Obesity, Morbid

What participants receive

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

  • abiliti system implantDevice

    Also called abiliti

    Subjects will receive implanted abiliti System.

  • Laparoscopic adjustable gastric band (Allergan Lap Band)Device

    Also called gastric band

    Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.

Study groups in NCT01448785
Study groupRoleWhat they receive
abiliti GroupActive comparatorSubjects will receive implanted abiliti System. The device will be activated to deliver therapy at implant. Gastric stimulation performance testing, therapy adjustment and dietary/exercise counseling will be conducted at each visit.
Receives: Device: abiliti system implant
Gastric Band GroupActive comparatorSubjects will receive an implanted laparoscopic adjustable gastric band. The subjects will have their band adjusted following the standard of care. Dietary/exercise counseling will be conducted at each visit.
Receives: Device: Laparoscopic adjustable gastric band (Allergan Lap Band)

What is being measured

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

  1. Non-inferiority of the abiliti therapy compared to adjustable gastric banding

    The non-inferiority of the abiliti therapy compared to adjustable gastric banding will be measured using a composite endpoint at the end of the study period. The success criteria will be the percentage of subjects in each group who meet all of the following criteria:

    • Achieve at least 20% excess weight loss (%EWL) from implant to end of the study period.
    • Experience no serious or severe adverse events related to the device or the procedure
    • No significant negative change in quality of life using the Impact Of Weight On Quality Of Life-Lite Questionnaire (IWQOL-Lite)

    Measured: 12 months

  2. Percentage of Responders

    Fifty (50 %) of the subject population must obtain an EWL ≥ 25%

    Measured: 12 months

  3. Safety

    • Incidence and seriousness of all adverse events.
    • Incidence of device or procedure-related adverse events
    • Frequency of clinically significant abnormal laboratory values as determined by the Investigator;

    Measured: 12 months

Secondary outcomes (4)

  1. Safety

    Frequency of device and procedure-related adverse events

    Measured: 6 and 12 months

  2. Quality of Life

    Change in the quality of life using the IWQOL-Lite questionnaire

    Measured: 6 and 12 months

  3. Eating Behavior

    Change in the eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ).

    Measured: 6 and 12 months

  4. Co-morbid Conditions

    Evaluation of the changes in blood pressure, lipid panel, HbA1c

    Measured: 6 and 12 months

Timeline

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

  1. First posted7 Oct 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJan 2013 (estimated)
  4. Study completionJan 2015 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01448785
Sponsor's protocol ID
CS-007-P
Status last verified
Oct 2011
First submitted
3 Oct 2011
Last updated
31 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • Morales-Conde S, Alarcon Del Agua I, Busetto L, Favretti F, Anselmino M, Rovera GM, Socas-Macias M, Barranco-Moreno A, Province-Azalde R, Torres AJ. Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months. Obes Surg. 2018 Jun;28(6):1766-1774. doi: 10.1007/s11695-017-3093-8.

    PubMed 29333595

  • Busetto L, Torres AJ, Morales-Conde S, Alarcon Del Agua I, Moretto C, Fierabracci P, Rovera G, Segato G, Rubio MA, Favretti F. Impact of the feedback provided by a gastric electrical stimulation system on eating behavior and physical activity levels. Obesity (Silver Spring). 2017 Mar;25(3):514-521. doi: 10.1002/oby.21760. Epub 2017 Feb 6.

    PubMed 28164463

  • Alarcon Del Agua I, Socas-Macias M, Busetto L, Torres-Garcia A, Barranco-Moreno A, Garcia de Luna PP, Morales-Conde S. Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation. Obes Surg. 2017 Jun;27(6):1573-1580. doi: 10.1007/s11695-016-2495-3.

    PubMed 28013450

Questions about this trial

What is this clinical trial studying?

A study testing abiliti system implant and Laparoscopic adjustable gastric band (Allergan Lap Band) in people with Obesity and Morbid Obesity, run by IntraPace, Inc at 15 sites in 6 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 12 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, Italy, United Kingdom, Spain, France and 1 more country. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Robert Nardelli (650-316-4065), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority of the abiliti therapy compared to adjustable gastric banding (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT01448785, which also lists 3 linked publications.

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 31 Oct 2011.

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Abiliti™ Treatment in Obese Subjects (NCT01448785) | AzTrials