Focus: Surgical Smoke During Laparoscopic SurgeryPhase 1/2InnervisionNCT01534832
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
A Phase 1/2 study testing Innervision Surgical Smoke Removal System in people with Focus: Surgical Smoke During Laparoscopic Surgery, run by Asalus Medical Instruments Limited at 1 site in United Kingdom.
Trial summary
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Focus: Surgical Smoke During Laparoscopic Surgery
- What is being tested?
- Innervision Surgical Smoke Removal System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Aug 2012
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age
- Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
- Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
Who cannot join
- <18 years of age
- Pregnant or lactating females
- Previous extensive abdominal surgery, which in the opinion of the Investigator presents a >5% risk of conversion to an open procedure being required
- Current participation in another device or drug study
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Llandough
Cardiff, Wales, CF64 2XX
About this study
Official title: Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.
Read the detailed description
The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.
- Being tested
- Innervision Surgical Smoke Removal System
- Keywords
- surgical smoke, laparoscopic surgery, impaired vision
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innervision Surgical Smoke Removal SystemDevice
Smoke removal by electrostatic precipitation
| Study group | Role | What they receive |
|---|---|---|
| Smoke clearance | Experimental | Smoke clearance device active Receives: Device: Innervision Surgical Smoke Removal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of a clear visual field during surgery
Measured: 3m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Surgical Smoke During Laparoscopic SurgeryStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asalus Medical Instruments Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jared Torkington, MBBS MS FRCS, Principal investigator, Cardiff and Vale UHB, Wales, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534832
- Sponsor's protocol ID
- AMIL/2011/INV01
- Acronym
- Innervision
- Status last verified
- Aug 2012
- First submitted
- 10 Feb 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01534832
- Acronym / sponsor ID
- Innervision / AMIL/2011/INV01
- Keywords
- surgical smoke, laparoscopic surgery, impaired vision
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asalus Medical Instruments LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Feb 2012 (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 study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.
Detailed description
The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoke clearance | Experimental | Device: Innervision Surgical Smoke Removal SystemSmoke clearance device active |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, at least 18 years of age
- Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
- Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
Key exclusion criteria (5 listed)
- <18 years of age
- Pregnant or lactating females
- Previous extensive abdominal surgery, which in the opinion of the Investigator presents a >5% risk of conversion to an open procedure being required
- Current participation in another device or drug study
- Unwilling or unable to provide informed consent
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 |
|---|---|---|
| Innervision Surgical Smoke Removal SystemSmoke removal by electrostatic precipitation | Device | Smoke clearance |
Primary outcome
Maintenance of a clear visual field during surgery
Time frame: 3m
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 15 Aug 2012.
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.
Jared Torkington, MBBS MS FRCS principal investigator
Cardiff and Vale UHB, Wales, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Innervision Surgical Smoke Removal System in people with Focus: Surgical Smoke During Laparoscopic Surgery, run by Asalus Medical Instruments Limited at 1 site in United Kingdom.
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 5 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 15 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 Kingdom. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maintenance of a clear visual field during surgery (time frame: 3m). 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 15 Aug 2012.