Patients Who Were Scheduled for General and Gynecological Laparoscopic ProceduresNCT02326870
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study
A study testing AutoLap in people with Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures, run by M.S.T. Medical Surgery Technology LTD. at 4 sites in 2 countries.
Trial summary
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
- What is being tested?
- AutoLap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2014to Mar 2016
- 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 cannot join
- Pregnancy
- Extensive adhesions that will preclude routine laparoscopic surgical approach.
- American Society of Anesthesiologists' (ASA) classification>2
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands2 sites
Meander Medisch Centrum
Amersfoort, 3800BM
University Medical Center Utrecht
Utrecht
About this study
Official title: Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
- Being tested
- AutoLap
- Keywords
- laparoscopic Cholecystectomy, laparoscope holder, gynecological laparoscopy procedures, fundoplication surgery, laparoscopic adnexal surgery, excision of endometriosis lesion, diagnostic laparoscopy procedures, right hemicolectomy, Diaphragmatic hernia
- Medical subject headings
- Hernia, Diaphragmatic
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 |
|---|---|---|
| The AutoLap system | Experimental | Use of the AutoLap system for controlling the laparoscope during the procedure Receives: Device: AutoLap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful "Follow Me" movements
Measured: during surgery
System set-up time
Measured: during surgery
Length of procedure
Measured: during surgery
Number of times that the laparoscope was removed for cleaning
Measured: during surgery
AutoLap evaluation questionnaire
Measured: post surgery
Secondary outcomes (1)
System repositioning
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Were Scheduled for General and Gynecological Laparoscopic ProceduresStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT02326870
- Sponsor's protocol ID
- AL-65-003
- Status last verified
- Sep 2016
- First submitted
- 21 Dec 2014
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02326870
- Acronym / sponsor ID
- AL-65-003
- Keywords
- laparoscopic Cholecystectomy, laparoscope holder, gynecological laparoscopy procedures, fundoplication surgery, laparoscopic adnexal surgery, excision of endometriosis lesion, diagnostic laparoscopy procedures, right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.S.T. Medical Surgery Technology LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Dec 2014 (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 performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The AutoLap system | Experimental | Device: AutoLapUse of the AutoLap system for controlling the laparoscope during the procedure |
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
Key exclusion criteria (3 listed)
- Pregnancy
- Extensive adhesions that will preclude routine laparoscopic surgical approach.
- American Society of Anesthesiologists' (ASA) classification>2
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 | The AutoLap system |
Primary outcome
Number of successful "Follow Me" movements
Time frame: during surgery
System set-up time
Time frame: during surgery
Length of procedure
Time frame: during surgery
Number of times that the laparoscope was removed for cleaning
Time frame: during surgery
AutoLap evaluation questionnaire
Time frame: post surgery
1 secondary outcome
System repositioning
Time frame: during 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 16 Sep 2016.
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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoLap in people with Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures, run by M.S.T. Medical Surgery Technology LTD. at 4 sites in 2 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 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 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, 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?
Number of successful "Follow Me" movements (time frame: during surgery). The study lists 5 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 16 Sep 2016.