General Laparoscopic Surgery CandidateNCT02346552
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
A study testing AutoLap in people with General Laparoscopic Surgery Candidate and Bariatric Laparoscopic Surgery Candidate, run by M.S.T. Medical Surgery Technology LTD. at 1 site in United States.
Trial summary
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate
- What is being tested?
- AutoLap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- 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
- Signed and dated Informed Consent Form (ICF).
- Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures
Who cannot join
- Extensive adhesions that will preclude routine laparoscopic surgical approach.
- Pregnancy
- 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
1 site in 1 country.
United States1 site
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
About this study
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
- Being tested
- AutoLap
- Keywords
- laparoscopic Cholecystectomy, laparoscope holder, Nissen fundoplication, paraesophageal hernia, sleeve surgery
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoLapDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Procedures will be performed with the AutoLpap system used for holding and controlling the movement of the laparoscope. Receives: Device: AutoLap |
| Group 2 | No intervention | Procedures will be performed with the assistance of human camera holder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image stability
measured by the vibrations of inertial sensors
Measured: during surgery, an expected average of 1 hour
Usability
The ease of use of the AutoLap system will be evaluated by a set of questionnaires
Measured: post surgery, an expected average of 3 minutes
Secondary outcomes (3)
System set-up time
Measured: during surgery, an expected average of 5 minutes
Length of surgery
Measured: during surgery, an expected average of 1 hour
The Number of times that the laparoscope was removed for cleaning
Measured: during surgery, an expected average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Laparoscopic Surgery CandidateStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitry Nepomnayshy, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346552
- Sponsor's protocol ID
- AL-65-004
- Status last verified
- Sep 2016
- First submitted
- 8 Jan 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02346552
- Acronym / sponsor ID
- AL-65-004
- Keywords
- laparoscopic Cholecystectomy, laparoscope holder, Nissen fundoplication, paraesophageal hernia, sleeve surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Jan 2015 (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 ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: AutoLapProcedures will be performed with the AutoLpap system used for holding and controlling the movement of the laparoscope. |
| Group 2 | No intervention | –Procedures will be performed with the assistance of human camera holder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated Informed Consent Form (ICF).
- Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures
Key exclusion criteria (3 listed)
- Extensive adhesions that will preclude routine laparoscopic surgical approach.
- Pregnancy
- Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
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 |
|---|---|---|
| AutoLap | Device | Group 1 |
Primary outcome
Image stability
Time frame: during surgery, an expected average of 1 hour
measured by the vibrations of inertial sensors
Usability
Time frame: post surgery, an expected average of 3 minutes
The ease of use of the AutoLap system will be evaluated by a set of questionnaires
3 secondary outcomes
System set-up time
Time frame: during surgery, an expected average of 5 minutes
Length of surgery
Time frame: during surgery, an expected average of 1 hour
The Number of times that the laparoscope was removed for cleaning
Time frame: during surgery, an expected average of 1 hour
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 29 Aug 2018.
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.
Dmitry Nepomnayshy, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoLap in people with General Laparoscopic Surgery Candidate and Bariatric Laparoscopic Surgery Candidate, run by M.S.T. Medical Surgery Technology LTD. 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 2 inclusion and 3 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 29 Aug 2018. 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 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?
Image stability (time frame: during surgery, an expected average of 1 hour). 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 29 Aug 2018.