CholecystectomyNCT00979186
A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
A study testing NOTES GEN 1 Toolbox in people with Cholecystectomy, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- NOTES GEN 1 Toolbox
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2010
- Phase
- Interventional
- 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
Who may be able to join
- Men and 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); and
- Have a negative serum pregnancy test (for women of childbearing potential);
- Have the study procedure attempted.
Who cannot join
- 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;
- History of open abdominal surgery;
Show all 18Show fewer
- 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 peritoneal 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;
- Previous diagnosis of intra-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; or
- Any condition which precludes compliance with the study (Investigator discretion).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Surgery, UCSD
San Diego, California, 92037
About this study
The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.
- Conditions
- Cholecystectomy
- Being tested
- NOTES GEN 1 Toolbox
- Keywords
- transgastric cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTES GEN 1 ToolboxDevice
Also called 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, and Tissue Apposition System.
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, and Tissue Apposition System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of procedures completed
Day of surgery only - study complete at end of prodecure.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Study Terminated - No enrollment, business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979186
- Sponsor's protocol ID
- CI-08-0005
- Status last verified
- Dec 2010
- First submitted
- 16 Sep 2009
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
- ClinicalTrials.gov ID
- NCT00979186
- Acronym / sponsor ID
- CI-08-0005
- Conditions
- Cholecystectomy
- Keywords
- transgastric cholecystectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Terminated - No enrollment, business decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Sep 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.
The study will document being able to successfully perform transgastric cholecystectomy (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)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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); and
- Have a negative serum pregnancy test (for women of childbearing potential);
Key exclusion criteria (18 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 ToolboxAlso: 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, and Tissue Apposition System.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, and Tissue Apposition System. | Device | – |
Primary outcome
Proportion of procedures completed
Time frame: 1 Day
Day of surgery only - study complete at end of prodecure.
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 29 Nov 2011.
Related trials for Cholecystectomy
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 recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Colorectal Adenoma, Cholecystectomy
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.
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 Cholecystectomy, 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 18 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 29 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?
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?
Proportion of procedures completed (time frame: 1 Day). 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 29 Nov 2011.