Gallbladder DiseaseNOTESNCT00889928
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
A study testing NOTES GEN 1 Toolbox in people with Gallbladder Disease, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gallbladder Disease
- What is being tested?
- NOTES GEN 1 Toolbox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2011
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women will be enrolled in this study who:
- Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
- At least 18 years of age;
- Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
- ASA Classification I or II (Appendix II);
- Have a negative serum pregnancy test (for women of childbearing potential); and
- Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.
Who cannot join
- Subjects will be excluded from the study for any of the following:
- BMI > 35;
- Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
- Suspicion of gallbladder cancer, tumor, polyps, or mass;
- Acute cholecystitis or acute pancreatitis;
- Presence of common bile duct stones;
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- History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test);
- Pelvic Inflammatory Disease;
- Evidence of abdominal abscess or mass;
- Diffuse peritonitis;
- Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
- Clinical diagnosis of sepsis;
- History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;
- History of peritoneal or vaginal trauma;
- Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
- Planned concurrent surgical procedure;
- Prior or planned major surgical procedure within 30 days before or after study procedure;
- History of transvaginal surgery;
- History of (or symptomatic for) abdominal adhesions;
- Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
- Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox;
- Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or
- Any condition which precludes compliance with the study (Investigator discretion).
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness
Chicago, Illinois, 60611
About this study
The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.
- Conditions
- Gallbladder Disease
- Being tested
- NOTES GEN 1 Toolbox
- Keywords
- gallbladder disease, cholecystectomy, gallbladder disease indicated for cholecystectomy
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTES GEN 1 ToolboxDevice
- Articulating Hook Knife
- Articulating Snare
- Articulating Needle Knife
- Articulating Graspers
- Articulating Biopsy Forceps
- Steerable Flex Trocar with Rotary Access Needle
- Flexible Bipolar Hemostasis Forceps
- Flexible Maryland Dissector
| Study group | Role | What they receive |
|---|---|---|
| cholecystectomy | Experimental | transvaginal cholecystectomy Receives: Device: NOTES GEN 1 Toolbox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Completion
Completion of procedure - transvaginal removal of the gallbladder
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2010
- Study completionAug 2011
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.
- Other trials for Gallbladder DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Hungness, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889928
- Sponsor's protocol ID
- CI-08-0004
- Acronym
- NOTES
- Status last verified
- Nov 2011
- First submitted
- 28 Apr 2009
- Last updated
- 24 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
- ClinicalTrials.gov ID
- NCT00889928
- Acronym / sponsor ID
- NOTES / CI-08-0004
- Conditions
- Gallbladder Disease
- Keywords
- gallbladder disease, cholecystectomy, gallbladder disease indicated for cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Posted 24 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cholecystectomy | Experimental | Device: NOTES GEN 1 Toolboxtransvaginal cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
- At least 18 years of age;
- Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
- ASA Classification I or II (Appendix II);
- Have a negative serum pregnancy test (for women of childbearing potential); and
Key exclusion criteria (23 listed)
- BMI > 35;
- Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
- Suspicion of gallbladder cancer, tumor, polyps, or mass;
- Acute cholecystitis or acute pancreatitis;
- Presence of common bile duct stones;
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 |
|---|---|---|
| NOTES GEN 1 Toolbox* Articulating Hook Knife * Articulating Snare * Articulating Needle Knife * Articulating Graspers * Articulating Biopsy Forceps * Steerable Flex Trocar with Rotary Access Needle * Flexible Bipolar Hemostasis Forceps * Flexible Maryland Dissector | Device | cholecystectomy |
Primary outcome
Procedure Completion
Time frame: Day of Surgery
Completion of procedure - transvaginal removal of the gallbladder
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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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.
Eric Hungness, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOTES GEN 1 Toolbox in people with Gallbladder Disease, run by Ethicon Endo-Surgery 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 7 inclusion and 23 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 24 Nov 2011. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2011). 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?
Procedure Completion (time frame: Day of Surgery). 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 24 Nov 2011.