SurgeryNCT06424418
Robotic Scope Cleaning Device
A study testing Robotic Scope Cleaner in people with Surgery, run by Boehringer Labs LLC at 2 sites in United States.
Trial summary
A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Robotic Scope Cleaner
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to consent
- undergoing a surgical robotic procedure
Who cannot join
- not suitable for a surgical procedure with the robot
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Health
New York, New York, 10016
Mark Bond, 646-754-7217
Micheal Zervos, MD
Temple University
Philadelphia, Pennsylvania, 19410
Daniel Eun, MD
About this study
Official title: 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.
- Conditions
- Surgery
- Being tested
- Robotic Scope Cleaner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Scope CleanerDevice
The device is used to clean the scope when it visualization becomes obstructed during a surgical procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Estimated 6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424418
- Sponsor's protocol ID
- Scope1
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study Validating The Safety And Efficacy of a Novel Robotic Scope Cleaner
- ClinicalTrials.gov ID
- NCT06424418
- Acronym / sponsor ID
- Scope1
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Boehringer Labs LLCIndustry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to consent
- undergoing a surgical robotic procedure
Key exclusion criteria (1 listed)
- not suitable for a surgical procedure with the robot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Scope CleanerThe device is used to clean the scope when it visualization becomes obstructed during a surgical procedure. | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Scope Cleaner in people with Surgery, run by Boehringer Labs LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of device (time frame: [Estimated 6 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.