General Laparoscopic SurgeriesNCT02934542
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
A study testing AutoLap system in people with General Laparoscopic Surgeries, run by M.S.T. Medical Surgery Technology LTD. at 1 site in Netherlands.
Trial summary
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Laparoscopic Surgeries
- What is being tested?
- AutoLap system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Feb 2018
- 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
- Aged ≥ 18 years
- Able to provide a written informed consent
Who cannot join
- Pregnancy
- Obesity (BMI >35 Kg/m2)
- Contra-indications for performing laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.
- Conditions
- General Laparoscopic Surgeries
- Being tested
- AutoLap system
- Keywords
- Laparoscope holder, Colon resection, Right hemicolectomy, Left hemicolectomy, Sigmoid resection, Anti-reflux, Hiatal hernia
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoLap systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in this group will undergo an elective standard laparoscopic procedure with a designated OR staff to maneuver the laparoscopic camera. The procedures will be performed according to the hospital and OR routine procedure. |
| AutoLap Group | Experimental | Patients in this group will undergo a laparoscopic procedure using the AutoLap system. In this group the surgeon will use the AutoLap system to hold and control the movements of the laparoscopic camera. Receives: Device: AutoLap system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in performing an operation with at least one OR person less
Measured: During surgery
Secondary outcomes (3)
Duration of the operation
Measured: During surgery
Number of times the laparoscope is removed for cleaning
Measured: During surgery
Usability evaluation
Measured: Up to two days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Laparoscopic SurgeriesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivo A. M. J. Broeders, MD, Principal investigator, Meander Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934542
- Sponsor's protocol ID
- AL-65-006-P
- Status last verified
- Sep 2017
- First submitted
- 5 Oct 2016
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
- ClinicalTrials.gov ID
- NCT02934542
- Acronym / sponsor ID
- AL-65-006-P
- Conditions
- General Laparoscopic Surgeries
- Keywords
- Laparoscope holder, Colon resection, Right hemicolectomy, Left hemicolectomy, Sigmoid resection, Anti-reflux, Hiatal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Oct 2016 (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 objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in this group will undergo an elective standard laparoscopic procedure with a designated OR staff to maneuver the laparoscopic camera. The procedures will be performed according to the hospital and OR routine procedure. |
| AutoLap Group | Experimental | Device: AutoLap systemPatients in this group will undergo a laparoscopic procedure using the AutoLap system. In this group the surgeon will use the AutoLap system to hold and control the movements of the laparoscopic camera. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 18 years
- Able to provide a written informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Obesity (BMI >35 Kg/m2)
- Contra-indications for performing laparoscopy
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 system | Device | AutoLap Group |
Primary outcome
Success rate in performing an operation with at least one OR person less
Time frame: During surgery
3 secondary outcomes
Duration of the operation
Time frame: During surgery
Number of times the laparoscope is removed for cleaning
Time frame: During surgery
Usability evaluation
Time frame: Up to two days post surgery
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.
- Individual participant dataSharing planned: No
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Swap Anesthetic Versus Continuous Desflurane in Adults Undergoing Bariatric Surgery
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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.
Ivo A. M. J. Broeders, MD principal investigator
Meander Medisch Centrum
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 system in people with General Laparoscopic Surgeries, run by M.S.T. Medical Surgery Technology LTD. at 1 site in Netherlands.
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 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?
Success rate in performing an operation with at least one OR person less (time frame: During 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 29 Aug 2018.