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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

NCT02702531 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-10-20

No results posted yet for this study

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.

Conditions

  • The Performance Evaluations of the FloShield Defogging and Cleaning System

Interventions

DEVICE

FloShield Defogging and Cleaning System

Sponsors & Collaborators

  • Tenon Hospital, Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-09-30
Completion
2016-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02702531 on ClinicalTrials.gov