Oncological Rectal SurgeryNCT04899726
Description of the Safety and Functionality of a Rectoscope (P201630551)
A study testing Rectoscope (P201630551) in people with Oncological Rectal Surgery, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncological Rectal Surgery
- What is being tested?
- Rectoscope (P201630551)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jul 2020to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years old.
- Patients with rectal cancer (15 cm or less from the anal margin), whether or not they have received neoadjuvant treatment, in whom cancer surgery is to be performed through the anterior (abdominal) route, whether laparoscopic or not.
- Patients who accept their participation in this study, after explaining the study details.
- Patients who sign the informed consent.
Who cannot join
- Patients who are going to undergo an abdominoperineal amputation or transanal surgery for rectal cancer.
- Patients who do not accept their participation in this study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Mario Álvarez Gallego, MD, 914975485, mario.alvarez@salud.madrid.org
About this study
Official title: Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery
Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon.
Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.
- Conditions
- Oncological Rectal Surgery
- Being tested
- Rectoscope (P201630551)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectoscope (P201630551)Device
Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oncology patients candidate for rectal surgery (tumors located up to 15 cm from the anal margin) and meet inclusion criteria. Rectoscope (P201630551) allows the identification of the distal section margin. Receives: Device: Rectoscope (P201630551) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events related to use of the device.
Safety. Clavien-Dindo classification will be used.
Measured: at immediate postoperative period
Evaluation of functionality
Categorical variable. 3 options:
- the device has worked without problems
- the device has worked, but with problems
- the device could not carry out its function.
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start14 Jul 2020
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncological Rectal 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899726
- Sponsor's protocol ID
- P201630551
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Safety and Functionality of a Rectoscope (P201630551) That Allows the Identification of the Distal Section Margin in Oncological Rectal Surgery
- ClinicalTrials.gov ID
- NCT04899726
- Acronym / sponsor ID
- P201630551
- Conditions
- Oncological Rectal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 24 May 2021 (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.
Most patients with rectal cancer receive neoadjuvant therapy. This usually causes a decrease in tumor size. In approximately 20% of patients who receive neoadjuvant therapy, the tumor disappears completely (complete pathological response), showing as a scar on the rectal mucosa, not noticeable from the rectal serosa, from outside the rectum, difficulting the identification of the tumor location by the surgeon.
Rectoscope (p201630551) allows the surgeon to view the illuminated rectum from the patient's abdomen, determining the appropriate point of section of the rectum.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Rectoscope (P201630551)Oncology patients candidate for rectal surgery (tumors located up to 15 cm from the anal margin) and meet inclusion criteria. Rectoscope (P201630551) allows the identification of the distal section margin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18 years old.
- Patients with rectal cancer (15 cm or less from the anal margin), whether or not they have received neoadjuvant treatment, in whom cancer surgery is to be performed through the anterior (abdominal) route, whether laparoscopic or not.
- Patients who accept their participation in this study, after explaining the study details.
- Patients who sign the informed consent.
Key exclusion criteria (2 listed)
- Patients who are going to undergo an abdominoperineal amputation or transanal surgery for rectal cancer.
- Patients who do not accept their participation in this study.
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 |
|---|---|---|
| Rectoscope (P201630551)Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery. | Device | Intervention |
Primary outcome
Number of adverse events related to use of the device.
Time frame: at immediate postoperative period
Safety. Clavien-Dindo classification will be used.
Evaluation of functionality
Time frame: at surgery
Categorical variable. 3 options: 1. the device has worked without problems 2. the device has worked, but with problems 3. the device could not carry out its function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectoscope (P201630551) in people with Oncological Rectal Surgery, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 4 inclusion and 2 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 26 May 2021. 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 Spain. 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?
Number of adverse events related to use of the device. (time frame: at immediate postoperative period). 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 26 May 2021.