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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01197222
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : September 9, 2010
Information provided by:
The Oregon Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Abdominal Surgery Device: EndoClear Lens Cleaning Device Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device
Study Start Date : March 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Arm Intervention/treatment
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 Name: Virtual Ports, Ltd
No Intervention: Control
EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01197222

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

Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic Identifier: NCT01197222     History of Changes
Other Study ID Numbers: 940
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: March 2009

Keywords provided by The Oregon Clinic:
Lens Cleaning Device