CholelithiasisPhase 1/2NCT00910325
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
A Phase 1/2 study testing Laparoscopic-assisted transvaginal cholecystectomy in people with Cholelithiasis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution. Read more about this study
- Who is it for?
- Ages 26 to 64 years, women only
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Laparoscopic-assisted transvaginal cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2012
- Phase
- Phase 1/2
- 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 26 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females who are postmenopausal or who no longer wish to bear children
- Females >25 years old and <65 years old
- Diagnosis of biliary disease requiring cholecystectomy
- American Society of Anesthesiology (ASA) Class I or II
- Females who are able to understand and willing to sign an informed consent document
Who cannot join
- Pregnancy
- BMI >= 30
- Patients who are still interested in childbearing
- Patients taking immunosuppressive medications or who are immunocompromised
- Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
- Patients with suspicion of gallbladder cancer
- Patients with history of previous open abdominal surgery
- Patients with untreated common bile duct stones
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.
- Conditions
- Cholelithiasis
- Being tested
- Laparoscopic-assisted transvaginal cholecystectomy
- Keywords
- Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic-assisted transvaginal cholecystectomyProcedure or surgery
Trans-vaginal Cholecystectomy with Laparoscopic Assistance
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and efficacy of the procedure
Measured: one year
Secondary outcomes (3)
Post-operative pain
Measured: one year
Time to return to work
Measured: one year
Time to return to daily activities
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startNov 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W. Rattner, MD, Massachusetts General Hospital
- Investigators
- David W Rattner, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910325
- Sponsor's protocol ID
- 2008p001938
- Status last verified
- Oct 2012
- First submitted
- 27 May 2009
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy
- ClinicalTrials.gov ID
- NCT00910325
- Acronym / sponsor ID
- 2008p001938
- Conditions
- Cholelithiasis
- Keywords
- Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 May 2009 (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.
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 26 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females who are postmenopausal or who no longer wish to bear children
- Females >25 years old and <65 years old
- Diagnosis of biliary disease requiring cholecystectomy
- American Society of Anesthesiology (ASA) Class I or II
- Females who are able to understand and willing to sign an informed consent document
Key exclusion criteria (8 listed)
- Pregnancy
- BMI >= 30
- Patients who are still interested in childbearing
- Patients taking immunosuppressive medications or who are immunocompromised
- Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid)
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 |
|---|---|---|
| Laparoscopic-assisted transvaginal cholecystectomyTrans-vaginal Cholecystectomy with Laparoscopic Assistance | Procedure or surgery | – |
Primary outcome
The safety and efficacy of the procedure
Time frame: one year
3 secondary outcomes
Post-operative pain
Time frame: one year
Time to return to work
Time frame: one year
Time to return to daily activities
Time frame: one year
Results and safety
The study was stopped early (reason given: The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
Related trials for Cholelithiasis
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
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.
David W Rattner, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laparoscopic-assisted transvaginal cholecystectomy in people with Cholelithiasis, run by Massachusetts General Hospital 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 5 inclusion and 8 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 30 Oct 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The alternative laparoscopic chole, has so little morbidity very few patients opt for a transvaginal approach when presented with the alternative). 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?
The safety and efficacy of the procedure (time frame: one 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 30 Oct 2012.