Surgery Clinical Trial
Official title:
A Proof of Concept Study Validating The Safety And Efficacy of a Novel Robotic Scope Cleaner
| NCT number | NCT06424418 |
| Other study ID # | Scope1 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2024 |
| Est. completion date | December 2024 |
| Verified date | May 2024 |
| Source | Boehringer Labs LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | December 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - able to consent - undergoing a surgical robotic procedure Exclusion Criteria: - not suitable for a surgical procedure with the robot |
| Country | Name | City | State |
|---|---|---|---|
| United States | NYU Langone Health | New York | New York |
| United States | Temple University | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Labs LLC | NYU Langone Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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] |
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