Comparison FloShield Air System Versus Clearify Visualization System (D-HELP)

Laparoscopic Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419911
• Other study ID #: FSA-0001
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2015
• Last updated: September 25, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2015
• Source: Minimally Invasive Devices, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Procedure:
• Laparoscopic surgery
gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;

Device:
• FloShield Defogging and Cleaning System
Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
• Clearify Defogging and Cleaning System
Single-use, ex vivo device to clean and defog the laparoscope camera lens

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Centennial Hills Medical Center	Las Vegas	Nevada
United States	South Miami Hospital	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Minimally Invasive Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0.5hr - 6hr	No