Weight LossNCT01497028
Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)
An observational study of Weight Loss, run by Jacksonville Surgical Associates at 2 sites in United States.
Trial summary
This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes Weight Loss Co-morbid disease resolution Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients between the ages of 18-80 years of age who are severly or morbidly obese and meet NIH and FDA criteria for baratric surgery (BMI>30+ co-morbid disease or BMI>35) who are undergoing baratric surgery at Jacksonville Surgical Associates, P.A. or Ventura Advanced Surgical Associates will be returned. All enrolled patients will be assigned to either the SLAGB (control)group or the PLAGB (study) group.
Who may be able to join
- Subjects must meet the following criteria to be eligible for study entry:
- Age between 18 - 80 years, and
- Severely or Morbidly obese:
- BMI > 35, or
- BMI > 30 + co-morbid obesity related disease condition
- Without any contraindications to bariatric surgery, and
- Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
- Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain
Who cannot join
- Subjects meeting the following criteria will be excluded from study entry:
- Any patient not meeting the inclusion criteria
- Patients with any major medical problems contraindicating surgery
- Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
- Patients who elect to undergo a surgery other than a PLAGB or SLAGB
- Pregnant or planning pregnancy within 12 months
Show all 10Show fewer
- Alcohol or drug addiction
- Established infection anywhere in the body at the time of surgery
- Previous history of other bariatric surgery (except LAGB)
- Family or patient history of autoimmune disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacksonville Surgical Associates
Jacksonville, Florida, 32216
Ventura Advanced Surgical Associates
Ventura, California, 93003
About this study
Official title: Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes
- Weight Loss
- Co-morbid disease resolution
- Conditions
- Weight Loss
- Being tested
- PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
- Keywords
- Co-morbid disease resolution
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.Procedure or surgery
PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Plicated Gastric Banding | Not described Receives: Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. | |
| Standard Gastric Banding | Not described Receives: Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Jacksonville Surgical Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Cywes, M.D., PhD, Jacksonville Surgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497028
- Sponsor's protocol ID
- PLAGB
- Status last verified
- Dec 2011
- First submitted
- 22 Nov 2011
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
- ClinicalTrials.gov ID
- NCT01497028
- Acronym / sponsor ID
- PLAGB
- Conditions
- Weight Loss
- Keywords
- Co-morbid disease resolution
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Jacksonville Surgical AssociatesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes
- Weight Loss
- Co-morbid disease resolution
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plicated Gastric Banding | – | Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. |
| Standard Gastric Banding | – | Procedure: PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients between the ages of 18-80 years of age who are severly or morbidly obese and meet NIH and FDA criteria for baratric surgery (BMI>30+ co-morbid disease or BMI>35) who are undergoing baratric surgery at Jacksonville Surgical Associates, P.A. or Ventura Advanced Surgical Associates will be returned. All enrolled patients will be assigned to either the SLAGB (control)group or the PLAGB (study) group.
Key inclusion criteria (8 listed)
- Age between 18 - 80 years, and
- Severely or Morbidly obese:
- Without any contraindications to bariatric surgery, and
- Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
- Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain
Key exclusion criteria (10 listed)
- Any patient not meeting the inclusion criteria
- Patients with any major medical problems contraindicating surgery
- Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
- Patients who elect to undergo a surgery other than a PLAGB or SLAGB
- Pregnant or planning pregnancy within 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial. | Procedure or surgery | Plicated Gastric Banding, Standard Gastric Banding |
Primary outcome
Weight Loss
Time frame: 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss, run by Jacksonville Surgical Associates at 2 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early. Results are not available in the source record.
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?
Weight Loss (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2015.