Disease or Lesions of the Anus, Rectum, or Distal ColonNCT03323060
Post-Market Clinical Follow-Up to Access & Visualize the Anus, Rectum, & Distal Colon During Transanal Procedures
An observational study of Disease or Lesions of the Anus, Rectum, or Distal Colon, run by Medrobotics Corporation at 2 sites in United States.
Trial summary
To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Disease or Lesions of the Anus, Rectum, or Distal Colon
- What is being tested?
- Transanal endoscopic surgical procedure
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Oct 2017to 30 Dec 2019
- Phase
- Observational
- 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
Study population: Subjects ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon
Who may be able to join
- ≥ 22 years of age
- Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.
Who cannot join
- Candidates are excluded if they < 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univsersity of Nevada School of Medicine
Las Vegas, Nevada, 89102
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Multicenter Post-Market Clinical Follow-Up of the Medrobotics Flex Robotic System and Flex Rectoscope Used for Accessing and Visualizing the Anus, Rectum, and Distal Colon During Transanal Procedures
To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures
- Being tested
- Transanal endoscopic surgical procedure
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal endoscopic surgical procedureDevice
Also called Laparoscopy
Resection of tumors or lesions
| Study group | Role | What they receive |
|---|---|---|
| Male and/or females ≥ 22 yrs old | ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure Receives: Device: Transanal endoscopic surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access and Visualization
Ability to access/touch with compatible flexible instruments and visualize/see with the scope/camera each of the four anatomical locations in the anus, rectum, and distal colon. The 4 areas to be accessed/touched and visualized/seen from the most proximal to the most distal are; Lower Rectum, Mid Rectum, Upper Rectum, Rectosigmoid Junction
Measured: 0-24 hours
Secondary outcomes (1)
Performance of transanal surgical procedure
Ability to complete the planned transanal surgical procedure using the Flex Robotic System, Flex Rectoscope and Flex compatible flexible instruments
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start11 Oct 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease or Lesions of the Anus, Rectum, or Distal ColonStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medrobotics Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323060
- Sponsor's protocol ID
- FLX-CRC-PMK-US-001
- Status last verified
- Aug 2019
- First submitted
- 20 Oct 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Post-Market Clinical Follow-Up of the Medrobotics Flex Robotic System and Flex Rectoscope Used for Accessing and Visualizing the Anus, Rectum, and Distal Colon During Transanal Procedures
- ClinicalTrials.gov ID
- NCT03323060
- Acronym / sponsor ID
- FLX-CRC-PMK-US-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medrobotics CorporationUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 26 Oct 2017 (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.
To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male and/or females ≥ 22 yrs old | – | Device: Transanal endoscopic surgical procedure≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon Transanal endoscopic surgical procedure |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥ 22 years of age requiring transanal procedures in the areas of the anus, rectum, and distal colon
Key inclusion criteria (2 listed)
- ≥ 22 years of age
- Candidate for transanal procedures in the areas of the anus, rectum, and distal colon.
Key exclusion criteria (1 listed)
- Candidates are excluded if they < 22 years of age and do not meet criteria for transanal surgery in the anus, rectum, and distal colon
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 |
|---|---|---|
| Transanal endoscopic surgical procedureAlso: LaparoscopyResection of tumors or lesions | Device | Male and/or females ≥ 22 yrs old |
Primary outcome
Access and Visualization
Time frame: 0-24 hours
Ability to access/touch with compatible flexible instruments and visualize/see with the scope/camera each of the four anatomical locations in the anus, rectum, and distal colon. The 4 areas to be accessed/touched and visualized/seen from the most proximal to the most distal are; Lower Rectum, Mid Rectum, Upper Rectum, Rectosigmoid Junction
1 secondary outcome
Performance of transanal surgical procedure
Time frame: 0-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease or Lesions of the Anus, Rectum, or Distal Colon, run by Medrobotics Corporation 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 13 Aug 2019. 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?
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?
Access and Visualization (time frame: 0-24 hours). 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 13 Aug 2019.