Weight LossROSNCT01084915
The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC)
An observational study of Weight Loss, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- How many people
- 840 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Jul 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received a SAGB-VC band from 2004-2008
Who may be able to join
- SAGB band placed from 2004-2008
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre
Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement.
This is the first retrospective clinical study of a large study population of >800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.
- Conditions
- Weight Loss
- Keywords
- Weight loss after SAGB VC band placement
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SAGB VC group | Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The amount of weight loss over time is researched
Measured: 2 months
Secondary outcomes (4)
Bariatric Analysis and Reporting Outcome System (BAROS) score
A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized
Measured: 2 months
Operating time
Operating time is inventorized
Measured: 2 months
Complications
Complications are inventorized
Measured: 2 months
Co-morbidities
The reduction of co-morbidities is inventorized
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJul 2011
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Jens Homan, Rijnstate Hospital
- Investigators
- F.J. Berends, MD, PhD, Principal investigator, Rijnstate Hospital The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084915
- Sponsor's protocol ID
- 680-070110-Aarts
- Acronym
- ROS
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2010
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre
- ClinicalTrials.gov ID
- NCT01084915
- Acronym / sponsor ID
- ROS / 680-070110-Aarts
- Conditions
- Weight Loss
- Keywords
- Weight loss after SAGB VC band placement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Mar 2010 (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.
Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement.
This is the first retrospective clinical study of a large study population of >800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAGB VC group | – | –Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received a SAGB-VC band from 2004-2008
Key inclusion criteria (1 listed)
- SAGB band placed from 2004-2008
Key exclusion criteria (1 listed)
- None
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
Weight loss
Time frame: 2 months
The amount of weight loss over time is researched
4 secondary outcomes
Bariatric Analysis and Reporting Outcome System (BAROS) score
Time frame: 2 months
Operating time
Time frame: 2 months
Complications
Time frame: 2 months
Co-morbidities
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
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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.
F.J. Berends, MD, PhD principal investigator
Rijnstate Hospital The Netherlands
1 site 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 Rijnstate Hospital 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 1 inclusion and 1 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 6 Mar 2014. 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?
Weight loss (time frame: 2 months). 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 6 Mar 2014.