Colorectal NeoplasmNCT05674123
Evaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions
A study testing Colonoscopy, Endoscopic Ultrasound and Medical Chart Review in people with Colorectal Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- Colonoscopy, Endoscopic Ultrasound and Medical Chart Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 10 Jun 2022
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 22 years (minimum age approved for use)
- Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification
- Colorectal lesions situated between 5 and 15 cm from the dentate line
- Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter
- Colorectal subepithelial lesions < 2 cm in size
- Absence of uncorrectable bleeding disorder or coagulopathy
Show all 9Show fewer
- Platelet count > 50,000
- International normalized ratio (INR) < 1.5
- Ability to give informed consent
Who cannot join
- Inability to receive general anesthesia
- Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)
- Excavated (0-III) colorectal lesions according to Paris classification
- Suboptimal colon preparation
- Clinical discretion of the provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study
This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.
OUTLINE:
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
- Conditions
- Colorectal Neoplasm
- Being tested
- Colonoscopy, Endoscopic Ultrasound, Medical Chart Review, Medical Device Usage and Evaluation, Resection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Undergo colonoscopy
Endoscopic UltrasoundProcedure or surgery
Also called endosonography, EUS
Undergo rectal endoscopic ultrasound
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
Medical Device Usage and EvaluationOther
Undergo resection with the Flex Robotic System
ResectionProcedure or surgery
Also called Robot-assisted surgical Resection
Undergo resection with the Flex Robotic System
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility (Flex Robotic System) | Experimental | Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening. Receives: Procedure: Colonoscopy; Procedure: Endoscopic Ultrasound; Other: Medical Chart Review; Other: Medical Device Usage and Evaluation; Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of complete en bloc resection
Rates of complete en bloc resection
Measured: Up to 2 years
Incidence of adverse events
The primary endpoint will be the Incidence of adverse events using the Flex Robotic System for distal colorectal lesions.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start15 Jan 2020
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Louis M Wong Kee Song, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674123
- Sponsor's protocol ID
- 19-009663
- Other IDs
- NCI-2022-09474, 19-009663
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study
- ClinicalTrials.gov ID
- NCT05674123
- Acronym / sponsor ID
- 19-009663
- Conditions
- Colorectal Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 6 Jan 2023 (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.
This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.
Detailed description
PRIMARY OBJECTIVE:
- To assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.
OUTLINE:
Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility (Flex Robotic System) | Experimental | Procedure: Colonoscopy, Procedure: Endoscopic Ultrasound, Other: Medical Chart Review, Other: Medical Device Usage and Evaluation, Procedure: ResectionPatients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 22 years (minimum age approved for use)
- Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification
- Colorectal lesions situated between 5 and 15 cm from the dentate line
- Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter
- Colorectal subepithelial lesions < 2 cm in size
Key exclusion criteria (5 listed)
- Inability to receive general anesthesia
- Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)
- Excavated (0-III) colorectal lesions according to Paris classification
- Suboptimal colon preparation
- Clinical discretion of the provider
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 |
|---|---|---|
| ColonoscopyUndergo colonoscopy | Procedure or surgery | Device Feasibility (Flex Robotic System) |
| Endoscopic UltrasoundAlso: endosonography, EUSUndergo rectal endoscopic ultrasound | Procedure or surgery | Device Feasibility (Flex Robotic System) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Device Feasibility (Flex Robotic System) |
| Medical Device Usage and EvaluationUndergo resection with the Flex Robotic System | Other | Device Feasibility (Flex Robotic System) |
| ResectionAlso: Robot-assisted surgical ResectionUndergo resection with the Flex Robotic System | Procedure or surgery | Device Feasibility (Flex Robotic System) |
Primary outcome
Rates of complete en bloc resection
Time frame: Up to 2 years
Rates of complete en bloc resection
Incidence of adverse events
Time frame: Up to 2 years
The primary endpoint will be the Incidence of adverse events using the Flex Robotic System for distal colorectal lesions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
Louis M Wong Kee Song principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy, Endoscopic Ultrasound and Medical Chart Review in people with Colorectal Neoplasm, run by Mayo Clinic at 1 site 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of complete en bloc resection (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 12 Jan 2023.