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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

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ClinicalTrials.gov Identifier: NCT02702531
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Pr. Emile Darai, Tenon Hospital, Paris

Brief 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.

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.


Condition or disease Intervention/treatment Phase
The Performance Evaluations of the FloShield Defogging and Cleaning System Device: FloShield Defogging and Cleaning System Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: FloShield
FloShield Air Laparoscopic Cleaning and Defogging System used during laparoscopic surgery
Device: FloShield Defogging and Cleaning System
Experimental: Water + Povidone-iodine Solution
Clearify Visualization with Water + Povidone-iodine Solutionused during laparoscopic surgery
Device: FloShield Defogging and Cleaning System



Primary Outcome Measures :
  1. number of Laparoscope removals during surgery [ Time Frame: 0.5hr - 6hr ]

Secondary Outcome Measures :
  1. medico economic cost effectiveness of the system [ Time Frame: 0.5hr - 6hr ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702531


Locations
France
Aphp, Tenon Hospital
Paris, Paris /france, France, 75020
Sponsors and Collaborators
Tenon Hospital, Paris

Responsible Party: Pr. Emile Darai, MD, PhD, Tenon Hospital, Paris
ClinicalTrials.gov Identifier: NCT02702531     History of Changes
Other Study ID Numbers: 2015-A01421-48
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016

Keywords provided by Pr. Emile Darai, Tenon Hospital, Paris:
Laparoscopic Surgery
FloShield Defogging and Cleaning System
Clearify Defogging and Cleaning System
gynecologic

Additional relevant MeSH terms:
Pharmaceutical Solutions
Iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes