Nano-Ceramic Coating for Laparoscope Lens

NCT03704259 | Completed FDA Device

• 1 other identifier: ZagazigELSU
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator tests the effectiveness of nano-ceramic coating when applied (painted) on laparoscope lens to protect it from fogging or smearing during laparoscopic operations

Conditions

Laparoscopic Surgical Procedures

Outcome Measures

Primary Outcomes (8)

• rate of fogging or smearing (per hour)

  The investigator calculates the number of times the lens is visibly fogged or smeared per hour of operation.

  One month

• rate of fogging or smearing (per single operation)

  The investigator calculates the number of times the lens is visibly fogged or smeared during a single operation.

  One month

• rate of extraction for cleaning (per hour)

  The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per hour of operation.

  One month

• Rate of extraction for cleaning (per operation)

  The investigator calculates the number of times the lens needs to be extracted from the abdomen for cleaning per single operation.

  One month

• The time consumption for lens cleaning (per hour)

  The investigator calculates the time consumption of the cleaning process as a total (in minutes) per hour.

  One month

• The time consumption for lens cleaning (per single operation)

  The investigator calculates the time consumption of the cleaning process as a total (in minutes) per single operation.

  One month

• Cleaning difficulty (per hour)

  The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour

  One month

• Cleaning difficulty (per single operation)

  The investigator calculates how many times the lens needed more measures for cleaning than simple wiping E.G immersion in hot saline per hour

  One month

Secondary Outcomes (1)

• Affecting the lens function

  One month

Interventions

Ceramic coating OTHER

coating the laparoscope lens with commercial brand ceramic coating, bought from car service centers specialized in such applications

Also known as: nan-ceramic coating

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted for laparoscopic operations

You may qualify if:

• Any patient requiring laparoscopic operation

You may not qualify if:

• Any intra-operative event or obstacle that requires conversion to open surgery

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Elsharkia, 44511, Egypt

Location

Related Publications (1)

• Manning TG, Papa N, Perera M, McGrath S, Christidis D, Khan M, O'Beirne R, Campbell N, Bolton D, Lawrentschuk N. Laparoscopic lens fogging: solving a common surgical problem in standard and robotic laparoscopes via a scientific model. Surg Endosc. 2018 Mar;32(3):1600-1606. doi: 10.1007/s00464-017-5772-x. Epub 2017 Aug 8.

  PMID: 28791559 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Master's degree, assistant lecturer of general surgery

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 12, 2018
• Study Start: September 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)