Laparoscopic SurgeryPhase 4NCT02419911
Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)
A Phase 4 study testing Laparoscopic surgery, FloShield Defogging and Cleaning System and Clearify Defogging and Cleaning System in people with Laparoscopic Surgery, run by Minimally Invasive Devices, Inc. at 3 sites in United States.
Trial summary
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Laparoscopic surgery, FloShield Defogging and Cleaning System and Clearify Defogging and Cleaning System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 4
- 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
- Female or Male;
- 18 years of age or older;
- Patient scheduled for gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery under the care of the study investigator;
- Suitable candidate for surgery
Who cannot join
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator);
- Use of Surgiquest AirSeal®;
- Use of humidified insufflation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45206
Centennial Hills Medical Center
Las Vegas, Nevada, 89149
South Miami Hospital
South Miami, Florida, 33143
About this study
Official title: Prospective, Randomized Comparison of the Use of FloShield Air System Versus Clearify Visualization System (D-HELP) During Laparoscopic Surgery to Evaluate the Operative Interruption for Lens Cleaning
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.
Read the detailed description
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery. The study will be randomized across two groups, one group will evaluate laparoscopic lens cleaning with D-HELP during laparoscopic surgery and the second group will evaluate laparoscopic lens cleaning using the FloShield Air System during laparoscopic surgery. Each surgery will be captured on video. Study parameters will be evaluated through review of each video by an independent evaluator.
- Conditions
- Laparoscopic Surgery
- Being tested
- Laparoscopic surgery, FloShield Defogging and Cleaning System, Clearify Defogging and Cleaning System
- Keywords
- gastrointestinal, gynecologic, urologic, bariatric, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
FloShield Defogging and Cleaning SystemDevice
Also called FloShield System
Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
Clearify Defogging and Cleaning SystemDevice
Single-use, ex vivo device to clean and defog the laparoscope camera lens
| Study group | Role | What they receive |
|---|---|---|
| FloShield | Other | FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery Receives: Procedure: Laparoscopic surgery; Device: FloShield Defogging and Cleaning System |
| Clearify | Other | Clearify Visualization System used during laparoscopic surgery Receives: Procedure: Laparoscopic surgery; Device: Clearify Defogging and Cleaning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Laparoscope removals during surgery
The performance evaluations of the FloShield Air System will be based the difference between the cohorts on the number of scope removals per surgery.
Measured: 0.5hr - 6hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minimally Invasive Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wayne Poll, MD, Study director, President and CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419911
- Sponsor's protocol ID
- FSA-0001
- Status last verified
- May 2015
- First submitted
- 1 Apr 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparison of the Use of FloShield Air System Versus Clearify Visualization System (D-HELP) During Laparoscopic Surgery to Evaluate the Operative Interruption for Lens Cleaning
- ClinicalTrials.gov ID
- NCT02419911
- Acronym / sponsor ID
- FSA-0001
- Conditions
- Laparoscopic Surgery
- Keywords
- gastrointestinal, gynecologic, urologic, bariatric, laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Minimally Invasive Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Apr 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.
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery.
Detailed description
This is a post market, prospective, comparison study of the use of the FloShield Air System versus Clearify™ Visualization System (D-HELP) during laparoscopic surgery. The study will be randomized across two groups, one group will evaluate laparoscopic lens cleaning with D-HELP during laparoscopic surgery and the second group will evaluate laparoscopic lens cleaning using the FloShield Air System during laparoscopic surgery. Each surgery will be captured on video. Study parameters will be evaluated through review of each video by an independent evaluator.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FloShield | Other | Procedure: Laparoscopic surgery, Device: FloShield Defogging and Cleaning SystemFloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery |
| Clearify | Other | Procedure: Laparoscopic surgery, Device: Clearify Defogging and Cleaning SystemClearify Visualization System used during laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or Male;
- 18 years of age or older;
- Patient scheduled for gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery under the care of the study investigator;
- Suitable candidate for surgery
Key exclusion criteria (3 listed)
- Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator);
- Use of Surgiquest AirSeal®;
- Use of humidified insufflation
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 |
|---|---|---|
| Laparoscopic surgerygastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery; | Procedure or surgery | Clearify, FloShield |
| FloShield Defogging and Cleaning SystemAlso: FloShield SystemSterile, single-use in vivo device to clean and defog the laparoscope camera lens | Device | FloShield |
| Clearify Defogging and Cleaning SystemSingle-use, ex vivo device to clean and defog the laparoscope camera lens | Device | Clearify |
Primary outcome
number of Laparoscope removals during surgery
Time frame: 0.5hr - 6hr
The performance evaluations of the FloShield Air System will be based the difference between the cohorts on the number of scope removals per 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 28 Sep 2015.
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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.
Wayne Poll, MD study director
President and CEO
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic surgery, FloShield Defogging and Cleaning System and Clearify Defogging and Cleaning System in people with Laparoscopic Surgery, run by Minimally Invasive Devices, Inc. at 3 sites 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 4 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 28 Sep 2015. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
number of Laparoscope removals during surgery (time frame: 0.5hr - 6hr). 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 28 Sep 2015.