Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid ResectionNCT01828580
Safety and Performance Evaluation of the AutoLap System
A study testing active laparoscope positioner (AutoLap) in people with Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection, run by M.S.T. Medical Surgery Technology LTD. at 3 sites in 3 countries.
Trial summary
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
- What is being tested?
- active laparoscope positioner (AutoLap)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2012to Jun 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated Informed Consent Form.
- Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Who cannot join
- Previous upper abdominal surgery and contraindications to Pneumoperitoneum.
- Pregnancy.
- Obesity (BMI >35 Kg/m2).
- Generalized peritonitis.
- Septic shock from cholangitis.
- Severe acute pancreatitis.
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- Uncorrected coagulopathy.
- Previous abdominal operations which prevent safe abdominal access or progression of the procedure.
- Advanced cirrhosis with failure of hepatic function.
- Suspected gallbladder cancer.
- Acute cholecystitis
- Presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Safety and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
- Being tested
- active laparoscope positioner (AutoLap)
- Keywords
- laparoscopic Cholecystectomy, Gallbladder removal, laparoscope holder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active laparoscope positioner (AutoLap)Device
| Study group | Role | What they receive |
|---|---|---|
| AutoLap | Experimental | Not described Receives: Device: active laparoscope positioner (AutoLap) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
No conversion to open surgery from laparoscopic surgery due to using the AutoLap system 2) No AutoLap system related operative complications, that require further clinical intervention
Measured: participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Performance evaluation
The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position
Measured: during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Secondary outcomes (4)
system set-up time
defined as the time required from connecting the AutoLap's ARM to the bed rail
Measured: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Average total procedure time
defined as the time from first abdominal incision until the surgical procedure is completed
Measured: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Number of times that the laparoscope was removed for cleaning
Measured: During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Usability evaluation
the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire. The questionnaire assesses the surgeon's satisfaction with the use of the AutoLap in regard to easiness of use, convenient of movement control and its ability to be used in the OR without interfering with the surgical flow
Measured: During surgery (at the end of the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid ResectionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828580
- Sponsor's protocol ID
- AL-65-001
- Status last verified
- Dec 2014
- First submitted
- 3 Apr 2013
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of the AutoLap System - a Feasibility Study
- ClinicalTrials.gov ID
- NCT01828580
- Acronym / sponsor ID
- AL-65-001
- Keywords
- laparoscopic Cholecystectomy, Gallbladder removal, laparoscope holder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Apr 2013 (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 main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AutoLap | Experimental | Device: active laparoscope positioner (AutoLap) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated Informed Consent Form.
- Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Key exclusion criteria (13 listed)
- Previous upper abdominal surgery and contraindications to Pneumoperitoneum.
- Pregnancy.
- Obesity (BMI >35 Kg/m2).
- Generalized peritonitis.
- Septic shock from cholangitis.
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 |
|---|---|---|
| active laparoscope positioner (AutoLap) | Device | AutoLap |
Primary outcome
Adverse events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 days
No conversion to open surgery from laparoscopic surgery due to using the AutoLap system 2) No AutoLap system related operative complications, that require further clinical intervention
Performance evaluation
Time frame: during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position
4 secondary outcomes
system set-up time
Time frame: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Average total procedure time
Time frame: during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Number of times that the laparoscope was removed for cleaning
Time frame: During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
Usability evaluation
Time frame: During surgery (at the end of the procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active laparoscope positioner (AutoLap) in people with Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection, run by M.S.T. Medical Surgery Technology LTD. at 3 sites in 3 countries.
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 2 inclusion and 13 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Italy, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events (time frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 days). The study lists 2 primary outcomes in all. 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 Dec 2014.