Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

Laparoscopic Abdominal Surgery Clinical Trial

Official title:

Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197222
• Other study ID #: 940
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2019
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.

Description:

The ability to perform laparoscopic surgery safely and effectively depends on the uninterrupted progression of the operation. Any interruptions to the normal workflow of the procedure threatens to cause distraction which in the least can lengthen the operative time leading to increased hospital operating costs and exposing the patient to unnecessary excess anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or technique resulting in injury to the patient.

Interruptions in the operating room can take many forms, from conversations to equipment malfunction. The goal of this study is to focus on one particular type of interruption unique to laparoscopic surgery - lens cleaning. It is quite common during the course of the procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from cautery devices. This necessitates having to remove the camera from the patient, cleaning it outside of the body, applying de-fog solution, reinserting it into the body, and having to reacquire the original camera position and image. This can be quite dangerous particularly in the middle of operative step, such as when there is ongoing bleeding, or when there are sharp or hot instruments within the body. Pilot data from own group demonstrates that the camera may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. >18 years of age

2. Patients undergoing laparoscopic abdominal surgery

Exclusion Criteria:

1. Patients with known coagulopathy or bleeding tendencies

2. Intra-abdominal abscesses

3. Pregnancy

4. Non-elective laparoscopic surgery.

Related Conditions & MeSH terms

• Laparoscopic Abdominal Surgery

Intervention

Device:
• EndoClear Lens Cleaning Device
EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.

Locations

Country	Name	City	State
United States	Legacy Good Samaritan	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

Country where clinical trial is conducted

United States,