NCT01197222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

September 8, 2010

Last Update Submit

August 29, 2019

Conditions

Laparoscopic Abdominal Surgery

Keywords

LaparoscopicEndoClearLens Cleaning Device

Study Arms (2)

EndoClear used

ACTIVE COMPARATOR

The EndoClear device is used during a laparoscopic abdominal surgery.

Device: EndoClear Lens Cleaning Device

Control

NO INTERVENTION

EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.

Interventions

EndoClear Lens Cleaning DeviceDEVICE

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

Also known as: Virtual Ports, Ltd
EndoClear used

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age
  • Patients undergoing laparoscopic abdominal surgery

You may not qualify if:

  • Patients with known coagulopathy or bleeding tendencies
  • Intra-abdominal abscesses
  • Pregnancy
  • Non-elective laparoscopic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy Good Samaritan

Portland, Oregon, 97210, United States

Location

Study Officials

  • Lee L Swanstrom, MD

    The Oregon Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 9, 2010

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

US(1)