Robotic Scope Cleaning Device

June 3, 2024 updated by: Boehringer Labs LLC

A Proof of Concept Study Validating The Safety And Efficacy of a Novel Robotic Scope Cleaner

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
        • Contact:
          • Mark Bond
          • Phone Number: 646-754-7217
        • Principal Investigator:
          • Micheal Zervos, MD
        • Sub-Investigator:
          • William Huang, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19410
        • Temple University
        • Contact:
          • Daniel Eun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • able to consent
  • undergoing a surgical robotic procedure

Exclusion Criteria:

  • not suitable for a surgical procedure with the robot

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of device
Time Frame: [Estimated 6 months]
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Labs LLC

Collaborators

NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Scope1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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