ObesityNCT01402505
Transvaginal NOTES Sleeve Gastrectomy
An observational study of Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Transvaginal NOTES sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2018
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic and have been cleared by the Bariatric and Metabolic Institute (BMI) team for bariatric surgery will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.
Who may be able to join
- Diagnosis of morbid obesity BMI > 40
- Female, age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES sleeve gastrectomy
Who cannot join
- Pregnant women
- BMI < 40
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Official title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.
- Conditions
- Obesity
- Being tested
- Transvaginal NOTES sleeve gastrectomy
- Keywords
- obesity, sleeve gastrectomy, transvaginal NOTES
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal NOTES sleeve gastrectomyProcedure or surgery
transvaginal NOTES sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal NOTES sleeve gastrectomy | Transvaginal NOTES sleeve gastrectomy Receives: Procedure: Transvaginal NOTES sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).
Measured: 1 year
Secondary outcomes (1)
To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startOct 2008
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Horgan, University of California, San Diego
- Investigators
- Santiago Horgan, M.D., FACS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402505
- Sponsor's protocol ID
- 081036, 141812
- Status last verified
- Mar 2020
- First submitted
- 21 Jul 2011
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT01402505
- Acronym / sponsor ID
- 081036, 141812
- Conditions
- Obesity
- Keywords
- obesity, sleeve gastrectomy, transvaginal NOTES
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 26 Jul 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 prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvaginal NOTES sleeve gastrectomy | – | Procedure: Transvaginal NOTES sleeve gastrectomyTransvaginal NOTES sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic and have been cleared by the Bariatric and Metabolic Institute (BMI) team for bariatric surgery will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.
Key inclusion criteria (4 listed)
- Diagnosis of morbid obesity BMI > 40
- Female, age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES sleeve gastrectomy
Key exclusion criteria (2 listed)
- Pregnant women
- BMI < 40
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 |
|---|---|---|
| Transvaginal NOTES sleeve gastrectomytransvaginal NOTES sleeve gastrectomy | Procedure or surgery | Transvaginal NOTES sleeve gastrectomy |
Primary outcome
To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).
Time frame: 1 year
1 secondary outcome
To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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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.
Santiago Horgan, M.D., FACS principal investigator
UCSD
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 Obesity, run by University of California, San Diego at 1 site 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 31 Mar 2020. 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 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 withdrawn before enrolling participants, so there are no results.
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?
To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection). (time frame: 1 year). 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 31 Mar 2020.