Transanal Endoscopic SurgeryNCT02807792
Perianal Operating Scope Feasibliity
A study testing Perianal access device in people with Transanal Endoscopic Surgery, run by University of Minnesota at 1 site in United States.
Trial summary
This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Transanal Endoscopic Surgery
- What is being tested?
- Perianal access device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2017to Jul 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 18 to 80
- In good health status
- Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses
Who cannot join
- Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
- Patients considerable unsuitable for inclusion in the study by their colorectal surgeon.
- Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure.
- Patients with known rectosigmoid infections.
- Patients with known rectosigmoid wall fragility.
- Patients with known rectosigmoid perforations.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Perianal Operating Scope Feasibility
This protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.
Read the detailed description
Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.
- Conditions
- Transanal Endoscopic Surgery
- Being tested
- Perianal access device
- Keywords
- Perianal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perianal access deviceDevice
Perianal access device
| Study group | Role | What they receive |
|---|---|---|
| Perianal access device | Experimental | Not described Receives: Device: Perianal access device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment of operative field dimensions measured in centimeters
The Outcome Measure Title implies the visual measurement that will be used to describe the potential operative field delineated by our experimental perianal access device. The description will, therefore, be primarily a qualitative visual assessment with the addition of estimated dimensions measured in centimeters for the length of the longitudinal and transverse fields encompassed by the blades of the access device. The collected measurement data will be aggregated, the numerical data averaged, and the visual perceptions integrated. The Time Frame for the individual study of each insertion will be two minutes or less. There is no chronic component to this feasibility analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transanal Endoscopic 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry Buchwald, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807792
- Sponsor's protocol ID
- 1601M83061
- Status last verified
- Apr 2017
- First submitted
- 18 May 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perianal Operating Scope Feasibility
- ClinicalTrials.gov ID
- NCT02807792
- Acronym / sponsor ID
- 1601M83061
- Conditions
- Transanal Endoscopic Surgery
- Keywords
- Perianal surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- 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 protocol will test a new prototype of a peri-anal access device, with increased flexible length and a captured operative field, for feasibility in patients immediately prior to their scheduled peri-anal procedure.
Detailed description
Research Methods: The insertion of the modified access device in five patients before their planned peri-anal procedure, which will subsequently be performed with standard instruments, will allow us to observe the ease of insertion, the expansion of the blades, and the creation of the operative field achieved. If necessary, we will modify our design based on these findings. When a successful, operating room prototype is established, the device will be suitable for clinical use and the stated benefits thereof.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perianal access device | Experimental | Device: Perianal access device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range 18 to 80
- In good health status
- Patients scheduled for a transanal procedure other than for anal lesions, e.g., hemorrhoids, fissures, abscesses
Key exclusion criteria (6 listed)
- Patients with physical characteristics that distort the rectal sigmoid anatomy, e.g., spinal lesions.
- Patients considerable unsuitable for inclusion in the study by their colorectal surgeon.
- Patients considered too frail or ill by their physician to undergo a 5-10 minute prolongation of their procedure.
- Patients with known rectosigmoid infections.
- Patients with known rectosigmoid wall fragility.
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 |
|---|---|---|
| Perianal access devicePerianal access device | Device | Perianal access device |
Primary outcome
Visual assessment of operative field dimensions measured in centimeters
Time frame: Baseline
The Outcome Measure Title implies the visual measurement that will be used to describe the potential operative field delineated by our experimental perianal access device. The description will, therefore, be primarily a qualitative visual assessment with the addition of estimated dimensions measured in centimeters for the length of the longitudinal and transverse fields encompassed by the blades of the access device. The collected measurement data will be aggregated, the numerical data averaged, and the visual perceptions integrated. The Time Frame for the individual study of each insertion will be two minutes or less. There is no chronic component to this feasibility analysis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Henry Buchwald, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perianal access device in people with Transanal Endoscopic Surgery, run by University of Minnesota 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 27 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual assessment of operative field dimensions measured in centimeters (time frame: Baseline). 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 27 Apr 2017.