## Protocol Section
### Identification Module
**NCT ID:** NCT06424418

**Brief Title:** Robotic Scope Cleaning Device

**Official Title:** A Proof of Concept Study Validating The Safety And Efficacy of a Novel Robotic Scope Cleaner

#### Organization Study ID Info
**ID:** Scope1
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Labs LLC
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** NYU Langone Health

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boehringer Labs LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** True

### Description Module

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

### Conditions Module

**Conditions:**

- Surgery

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Robotic Scope Cleaner

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** feasibility of device

**Time Frame:** [Estimated 6 months]

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* able to consent
* undergoing a surgical robotic procedure

Exclusion Criteria:

* not suitable for a surgical procedure with the robot

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Name:** Mark Bond

- **Phone:** 646-754-7217

- **Role:** CONTACT

***Contact 2:***

- **Name:** Micheal Zervos, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** William Huang, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** NYU Langone Health

**State:** New York

**Zip:** 10016

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
