Morbid ObesityNCT00999661
A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
An observational study of Morbid Obesity, run by Ethicon Endo-Surgery at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- How many people
- 231 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2009to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.
Who may be able to join
- Received an implant with the Realize Band-C according to the following indications for use:
- Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions.
- Male and female adult patients (adult is defined as 18 years of age or older)
- Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.
- Able to comprehend, follow, and give signed informed consent.
Who cannot join
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
- Severe cardiopulmonary disease or other serious organic disease;
- Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
- Portal hypertension;
- Anomalies of the gastrointestinal tract such as atresia or stenosis;
- Cirrhosis of the liver;
Show all 13Show fewer
- Chronic pancreatitis;
- Localized or systemic infection;
- On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;
- Unable or unwilling to comply with dietary restrictions required by this procedure;
- Known allergy to materials contained in the gastric band or its Injection Port;
- Women who are pregnant;
- Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Celebration, Florida
Study site
Charlotte, North Carolina
Study site
Holland, Michigan
Study site
Houston, Texas
Study site
Joliet, Illinois
Study site
Los Angeles, California
Study site
Patchogue, New York
About this study
Official title: A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients
The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.
- Conditions
- Morbid Obesity
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Excess Weight Change From Baseline to 24 Months
Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
Measured: Baseline to 24 months
Secondary outcomes (2)
% Excess Weight Change From Baseline to 12 Months
Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
Measured: Baseline to 12 months
Change in Body Mass Index From Baseline to 24 Months
Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999661
- Sponsor's protocol ID
- CI-09-0007
- Status last verified
- Jan 2014
- First submitted
- 20 Oct 2009
- Last updated
- 7 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Schwiers M, Gutierrez M. Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):885-93. doi: 10.1016/j.soard.2013.02.009. Epub 2013 Mar 14.
PubMed 23642493Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Rodriguez CE, Gutierrez M. Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population. Surg Obes Relat Dis. 2012 May-Jun;8(3):288-95. doi: 10.1016/j.soard.2011.05.004. Epub 2011 May 20.
PubMed 21775219
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT00999661
- Acronym / sponsor ID
- CI-09-0007
- Conditions
- Morbid Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Posted 7 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.
Key inclusion criteria (5 listed)
- Received an implant with the Realize Band-C according to the following indications for use:
- Able to comprehend, follow, and give signed informed consent.
Key exclusion criteria (13 listed)
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
- Severe cardiopulmonary disease or other serious organic disease;
- Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
- Portal hypertension;
- Anomalies of the gastrointestinal tract such as atresia or stenosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Excess Weight Change From Baseline to 24 Months
Time frame: Baseline to 24 months
Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
2 secondary outcomes
% Excess Weight Change From Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Body Mass Index From Baseline to 24 Months
Time frame: Baseline to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23642493Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Schwiers M, Gutierrez M. Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):885-93. doi: 10.1016/j.soard.2013.02.009. Epub 2013 Mar 14.
- Results publication: PubMed 21775219Cunneen SA, Brathwaite CE, Joyce C, Gersin K, Kim K, Schram JL, Wilson EB, Rodriguez CE, Gutierrez M. Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population. Surg Obes Relat Dis. 2012 May-Jun;8(3):288-95. doi: 10.1016/j.soard.2011.05.004. Epub 2011 May 20.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Ethicon Endo-Surgery at 7 sites in United States.
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 5 inclusion and 13 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 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Excess Weight Change From Baseline to 24 Months (time frame: Baseline to 24 months). 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 NCT00999661, which also lists 2 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 7 Feb 2014.