CholelithiasisNCT00486655
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
A study testing NOTES-Assisted Cholecystectomy in people with Cholelithiasis and Cholecystitis, run by USGI Medical at 1 site in United States.
Trial summary
This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cholelithiasis, Cholecystitis
- What is being tested?
- NOTES-Assisted Cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2007
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to undergo general anesthesia
- Age >= 18 yrs. of age and <= 85 yrs. of age
- Ability to give informed consent
Who cannot join
- Acute cholecystitis
- BMI >= 40
- Contraindicated for EGD
- Presence of common duct stones
- Presence of esophageal stricture
- Altered gastric anatomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assisted Laparoscopic Cholecystectomy Surgery
This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.
Read the detailed description
A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.
A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.
- Conditions
- Cholelithiasis, Cholecystitis
- Being tested
- NOTES-Assisted Cholecystectomy
- Keywords
- Cholecystectomy, NOTES, Transgastric
- Medical subject headings
- Cholelithiasis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTES-Assisted CholecystectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: 2 weeks
Secondary outcomes (1)
Incidence of complications
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startMay 2007
- Study completionJun 2007
Why it stopped: Change of Focus for the company
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.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USGI Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee Swanstrom, MD, Principal investigator, Oregon Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486655
- Sponsor's protocol ID
- LS0701
- Status last verified
- Aug 2012
- First submitted
- 12 Jun 2007
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT00486655
- Acronym / sponsor ID
- LS0701
- Conditions
- Cholelithiasis, Cholecystitis
- Keywords
- Cholecystectomy, NOTES, Transgastric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of Focus for the company
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- USGI MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Jun 2007 (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 study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.
Detailed description
A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.
A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to undergo general anesthesia
- Age >= 18 yrs. of age and <= 85 yrs. of age
- Ability to give informed consent
Key exclusion criteria (6 listed)
- Acute cholecystitis
- BMI >= 40
- Contraindicated for EGD
- Presence of common duct stones
- Presence of esophageal stricture
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-Assisted Cholecystectomy | Procedure or surgery | – |
Primary outcome
Quality of Life
Time frame: 2 weeks
1 secondary outcome
Incidence of complications
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Change of Focus for the company). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
Related trials for Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Lee Swanstrom, MD principal investigator
Oregon Clinic
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-Assisted Cholecystectomy in people with Cholelithiasis and Cholecystitis, run by USGI Medical 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 3 inclusion and 6 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 8 Aug 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.
Are results available for this study?
The study was stopped early (reason given: Change of Focus for the company). 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?
Quality of Life (time frame: 2 weeks). 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 8 Aug 2012.