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

This study has been completed.
Sponsor:
Information provided by:
The Oregon Clinic
ClinicalTrials.gov Identifier:
NCT01197222
First received: September 8, 2010
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Laparoscopic Abdominal Surgery
Device: EndoClear Lens Cleaning Device
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

Resource links provided by NLM:


Further study details as provided by The Oregon Clinic:

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EndoClear used
The EndoClear device is used during a laparoscopic abdominal surgery.
Device: EndoClear Lens Cleaning Device
EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.
Other Names:
  • Virtual Ports, Ltd
  • EndoClear Lens Cleaning Device
No Intervention: Control
EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197222

Locations
United States, Oregon
Legacy Good Samaritan
Portland, Oregon, United States, 97210
Sponsors and Collaborators
The Oregon Clinic
Investigators
Principal Investigator: Lee L Swanstrom, MD The Oregon Clinic
  More Information

No publications provided

Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01197222     History of Changes
Other Study ID Numbers: 940
Study First Received: September 8, 2010
Last Updated: September 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Oregon Clinic:
Laparoscopic
EndoClear
Lens Cleaning Device

ClinicalTrials.gov processed this record on August 19, 2014