The Performance Evaluations of the FloShield Defogging and Cleaning SystemPhase 4NCT02702531
Prospective, Randomized Comparison of the Use of FloShield Air System ® Versus the Referenced Technic (Water + Povidone-Iodine Solution) During Gynecologic Endoscopic Surgery to Evaluate the Operative Lens Vision Quality
A Phase 4 study testing FloShield Defogging and Cleaning System in people with The Performance Evaluations of the FloShield Defogging and Cleaning System, run by Tenon Hospital, Paris at 1 site in France.
Trial summary
Endoscopic surgical procedures are becoming more common in all surgical specialties including gynecology that was one of the pioneers in this field specialties. Maintaining a quality field of view is important not only to patient safety but also for the quality of surgery and reduced surgery time. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- The Performance Evaluations of the FloShield Defogging and Cleaning System
- What is being tested?
- FloShield Defogging and Cleaning System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Oct 2016
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female or Male; 18 years of age or older; Patient scheduled for gynecologic paroscopic 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
1 site in 1 country.
About this study
Endoscopic surgical procedures are becoming more common in all surgical specialties including gynecology that was one of the pioneers in this field specialties.
Maintaining a quality field of view is important not only to patient safety but also for the quality of surgery and reduced surgery time.
Read more
The lenses of vision which are located at the distal end of the optical vision are during endoscopic surgery in direct contact with the anatomical structures. These lenses are found soiled by several phenomena whose appearance of a mist which constitutes a major obstacle to a clear field.
The alteration of the vision requires the surgeon extraction optics in order to achieve a cleaning of the lens. This cleaning is carried out as many times as necessary. Many strategies have been developed to improve the quality of vision. These methods relate to both the development of new optical vision but also the development of the lens cleaning material. In practice, the cleaning is carried out using a sterile swab sterile saline associated with the betadine iodine.
Recently a new material called "FloShield Air System Vision System" has been proposed and has the particularity to combine both anti-fog product and a temperature control system in contact with the lens in order to fight against condensation and smoke. The purpose of this is to improve the quality of vision by reducing the fogging phenomenon and no change of the temperature in contact with the lens (moisture reduction). Accordingly, it is assumed a reduction in the number of stay and a reduction in the specific operative time associated with this cleaning.
In this context, we wish to evaluate the effectiveness of FloShield Air System vision system on the basis of a comparative, prospective, randomized against the reference method (sterile water solution + Betadine) during endoscopic surgery gynecology.
Read the detailed description
The reduction in vision during endoscopic surgery is a common problem for all surgical specialties and recurring. Studies of the pathophysiological mechanisms explaining the visual impairment by fogging emphasize the role of intraperitoneal temperature and moisture in contact with the optical lens. To this can be added two other causes of impaired vision are fluid projections and passively encountered tissues during exploration (eg, blood, fat, and ascites) and products of reactions of tissue during surgery for example, the outcome of smoke using coagulation material or section. In these situations the vision may be impaired in critical times during which an optimal view is needed to improve the quality of surgery.
A report by the World Health Organization was intended to identify the consequences of impaired vision during laparoscopic surgery. It is emphasized that impaired vision can contribute to surgical errors such as the use of a device incorrectly or displacement of the instruments on structures other than those intended. Moreover, it is reported an increase in the operative time associated with suboptimal view. Finally, the psychological dimension on the disruption of the surgeon is raised with a risk of difficulty of the procedure. To minimize these problems anti mist vision solutions combined with condensed water vapor spray system are among others marketed in recent years.
The action mechanism of these systems is to distribute steam droplets condensed on the surface of the cold lens to improve the quality of vision. Most, however, require cleaning of optics, but with less theoretical frequency. Although their use is reported in the literature their use has never been evaluated on the basis of a robust methodology.
Alternative methods readily available such as povidone iodine act similarly and are significantly less expensive (at least 10 times) than the above mentioned materials. No comparative study is currently available to support the effectiveness of these materials to the reference method inexpensive but partially effective. Their use is based solely on experience and expert opinion.
Vision device "FloShield Air System" was developed. We offer a comparative evaluation of the effectiveness of FloShield Air System vision system on the basis of a comparative, prospective, randomized against the reference method (sterile water + Betadine) during a gynecologic endoscopic surgery.
We propose to carry out a single-center, randomized, prospective trial comparing the efficacy in terms of reducing the number of cleaning FloShield Air System vision system, from a prospective, randomized during endoscopic surgery in gynecology.
After evaluation of the International Register of Clinical Trials Registry (https://clinicaltrials.gov/ct2/about-site) of the National Institutes of Health American no ongoing trial or released is interested or not interested at effectiveness of FloShield Air System vision device during endoscopic surgery in gynecology specifically on the primary endpoint.
Currently, the only Recruiting trial which concerns the system is entitled "Comparison FloShield Air System Versus clearify Visualization System (D-HELP)) (NCT02419911)." This is a non-academic comparative prospective trial efficiency.
The originality of our protocol resides in five points:
- His academic nature: the promoter is the University Hospital Tenon Hospital (AP-HP)
- It attempts to answer a clinical question frequently in clinical practice
- The feasibility: experience and surgical volume recruiting center in the endoscopic management should help support the computing power.
- Its safety for the patient
- The methodological basis helps support a level I evidence for this new material
- Being tested
- FloShield Defogging and Cleaning System
- Keywords
- Laparoscopic Surgery, FloShield Defogging and Cleaning System, Clearify Defogging and Cleaning System, gynecologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloShield Defogging and Cleaning SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| FloShield | Experimental | FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery Receives: Device: FloShield Defogging and Cleaning System |
| Water + Povidone-iodine Solution | Experimental | Clearify Visualization with Water + Povidone-iodine Solutionused during laparoscopic surgery Receives: Device: FloShield 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
Measured: 0.5hr - 6hr
Secondary outcomes (2)
medico economic cost effectiveness of the system
Measured: 0.5hr - 6hr
Evaluation of the quality of vision by the surgeon and his assistant end of the procedure using a visual analog scale
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 posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Performance Evaluations of the FloShield Defogging and Cleaning SystemStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenon Hospital, Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Emile Darai, Tenon Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702531
- Sponsor's protocol ID
- 2015-A01421-48
- Status last verified
- Oct 2016
- First submitted
- 3 Mar 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
Publications
Bendifallah S, Salakos E, Naoura I, Aristizabal P, Furet E, Zilberman S, Ballester M, Darai E. Prospective, randomized comparison of the use of FloShield Air System(R) versus the reference technique (water + povidone-iodine solution) during gynecologic endoscopic surgery to evaluate the operative lens vision quality. Surg Endosc. 2018 Mar;32(3):1593-1599. doi: 10.1007/s00464-017-5642-6. Epub 2017 Jun 22.
PubMed 28643058
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. 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 the Referenced Technic (Water + Povidone-Iodine Solution) During Gynecologic Endoscopic Surgery to Evaluate the Operative Lens Vision Quality
- ClinicalTrials.gov ID
- NCT02702531
- Acronym / sponsor ID
- 2015-A01421-48
- Keywords
- Laparoscopic Surgery, FloShield Defogging and Cleaning System, Clearify Defogging and Cleaning System, gynecologic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tenon Hospital, ParisUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Mar 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.
Endoscopic surgical procedures are becoming more common in all surgical specialties including gynecology that was one of the pioneers in this field specialties.
Maintaining a quality field of view is important not only to patient safety but also for the quality of surgery and reduced surgery time.
The lenses of vision which are located at the distal end of the optical vision are during endoscopic surgery in direct contact with the anatomical structures. These lenses are found soiled by several phenomena whose appearance of a mist which constitutes a major obstacle to a clear field.
The alteration of the vision requires the surgeon extraction optics in order to achieve a cleaning of the lens. This cleaning is carried out as many times as necessary. Many strategies have been developed to improve the quality of vision. These methods relate to both the development of new optical vision but also the development of the lens cleaning material. In practice, the cleaning is carried out using a sterile swab sterile saline associated with the betadine iodine.
Recently a new material called "FloShield Air System Vision System" has been proposed and has the particularity to combine both anti-fog product and a temperature control system in contact with the lens in order to fight against condensation and smoke. The purpose of this is to improve the quality of vision by reducing the fogging phenomenon and no change of the temperature in contact with the lens (moisture reduction). Accordingly, it is assumed a reduction in the number of stay and a reduction in the specific operative time associated with this cleaning.
In this context, we wish to evaluate the effectiveness of FloShield Air System vision system on the basis of a comparative, prospective, randomized against the reference method (sterile water solution + Betadine) during endoscopic surgery gynecology.
Detailed description
The reduction in vision during endoscopic surgery is a common problem for all surgical specialties and recurring. Studies of the pathophysiological mechanisms explaining the visual impairment by fogging emphasize the role of intraperitoneal temperature and moisture in contact with the optical lens. To this can be added two other causes of impaired vision are fluid projections and passively encountered tissues during exploration (eg, blood, fat, and ascites) and products of reactions of tissue during surgery for example, the outcome of smoke using coagulation material or section. In these situations the vision may be impaired in critical times during which an optimal view is needed to improve the quality of surgery.
A report by the World Health Organization was intended to identify the consequences of impaired vision during laparoscopic surgery. It is emphasized that impaired vision can contribute to surgical errors such as the use of a device incorrectly or displacement of the instruments on structures other than those intended. Moreover, it is reported an increase in the operative time associated with suboptimal view. Finally, the psychological dimension on the disruption of the surgeon is raised with a risk of difficulty of the procedure. To minimize these problems anti mist vision solutions combined with condensed water vapor spray system are among others marketed in recent years.
The action mechanism of these systems is to distribute steam droplets condensed on the surface of the cold lens to improve the quality of vision. Most, however, require cleaning of optics, but with less theoretical frequency. Although their use is reported in the literature their use has never been evaluated on the basis of a robust methodology.
Alternative methods readily available such as povidone iodine act similarly and are significantly less expensive (at least 10 times) than the above mentioned materials. No comparative study is currently available to support the effectiveness of these materials to the reference method inexpensive but partially effective. Their use is based solely on experience and expert opinion.
Vision device "FloShield Air System" was developed. We offer a comparative evaluation of the effectiveness of FloShield Air System vision system on the basis of a comparative, prospective, randomized against the reference method (sterile water + Betadine) during a gynecologic endoscopic surgery.
We propose to carry out a single-center, randomized, prospective trial comparing the efficacy in terms of reducing the number of cleaning FloShield Air System vision system, from a prospective, randomized during endoscopic surgery in gynecology.
After evaluation of the International Register of Clinical Trials Registry (https://clinicaltrials.gov/ct2/about-site) of the National Institutes of Health American no ongoing trial or released is interested or not interested at effectiveness of FloShield Air System vision device during endoscopic surgery in gynecology specifically on the primary endpoint.
Currently, the only Recruiting trial which concerns the system is entitled "Comparison FloShield Air System Versus clearify Visualization System (D-HELP)) (NCT02419911)." This is a non-academic comparative prospective trial efficiency.
The originality of our protocol resides in five points:
- His academic nature: the promoter is the University Hospital Tenon Hospital (AP-HP)
- It attempts to answer a clinical question frequently in clinical practice
- The feasibility: experience and surgical volume recruiting center in the endoscopic management should help support the computing power.
- Its safety for the patient
- The methodological basis helps support a level I evidence for this new material
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FloShield | Experimental | Device: FloShield Defogging and Cleaning SystemFloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery |
| Water + Povidone-iodine Solution | Experimental | Device: FloShield Defogging and Cleaning SystemClearify Visualization with Water + Povidone-iodine Solutionused during laparoscopic surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female or Male; 18 years of age or older; Patient scheduled for gynecologic paroscopic surgery under the care of the study investigator; Suitable candidate for surgery
Key exclusion criteria (1 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 |
|---|---|---|
| FloShield Defogging and Cleaning System | Device | FloShield, Water + Povidone-iodine Solution |
Primary outcome
number of Laparoscope removals during surgery
Time frame: 0.5hr - 6hr
2 secondary outcomes
medico economic cost effectiveness of the system
Time frame: 0.5hr - 6hr
Evaluation of the quality of vision by the surgeon and his assistant end of the procedure using a visual analog scale
Time frame: 0.5hr - 6hr
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 20 Oct 2016.
- Derived from this study: PubMed 28643058Bendifallah S, Salakos E, Naoura I, Aristizabal P, Furet E, Zilberman S, Ballester M, Darai E. Prospective, randomized comparison of the use of FloShield Air System(R) versus the reference technique (water + povidone-iodine solution) during gynecologic endoscopic surgery to evaluate the operative lens vision quality. Surg Endosc. 2018 Mar;32(3):1593-1599. doi: 10.1007/s00464-017-5642-6. Epub 2017 Jun 22.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FloShield Defogging and Cleaning System in people with The Performance Evaluations of the FloShield Defogging and Cleaning System, run by Tenon Hospital, Paris at 1 site in France.
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 1 inclusion and 1 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 20 Oct 2016. 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 France. 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?
On the ClinicalTrials.gov record for NCT02702531, which also lists 1 linked publication.
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 20 Oct 2016.