NCT06424418

Brief Summary

A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 26, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

April 26, 2024

Last Update Submit

June 3, 2024

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • feasibility of device

    Study to determine if the device works as intended. A questionnaire will be filled out by the operating surgeon. Questions include the number of cleans, time to clean, ease of use, etc.

    [Estimated 6 months]

Interventions

Robotic Scope CleanerDEVICE

The device is used to clean the scope when it visualization becomes obstructed during a surgical procedure.

Eligibility Criteria

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

You may qualify if:

  • able to consent
  • undergoing a surgical robotic procedure

You may not qualify if:

  • not suitable for a surgical procedure with the robot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYU Langone Health

New York, New York, 10016, United States

Location

Temple University

Philadelphia, Pennsylvania, 19410, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 22, 2024

Study Start

June 1, 2024

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)