Gastrointestinal PolypsNCT05141032
Pathfinder Registry
An observational study of Gastrointestinal Polyps, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study collects information regarding your procedure. No changes will be done to your procedure and you are asked to consent for the use of your data in our database. You are being asked to be in this research study because you have a gastrointestinal lesion that needs to be removed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Polyps
- What is being tested?
- Endoscopic Submucosal Dissection with Pathfinder/Overtube device
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 1 Nov 2023
- How long will I take part?
- 3 Years
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have been found to have duodenal or colon polyps will be identified as potential suitable subjects.
Who may be able to join
- Adult patients (18-80 years) Any gastrointestinal polyp that has been deemed appropriate for endoscopic removal.
Who cannot join
- Pregnant patients
- Prisoners
- Unable to sign consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Registry of Endoscopic Resection Procedures Performed With the Assistance of a Novel Rigidizing Overtube
This study collects information regarding your procedure. No changes will be done to your procedure and you are asked to consent for the use of your data in our database. You are being asked to be in this research study because you have a gastrointestinal lesion that needs to be removed. We remove these lesions endoscopically as part of the standard of care at Baylor St. Luke Medical Center, and we will be using a FDA approved device known as the Pathfinder Rigidization Overtube to assist with the removal of the polyp. This study is important because this is a relatively new procedure; although it is a part of your standard of care it is not done in many hospitals. We would like to document the outcomes and results of such procedures to continuously improve our standard of care.
Read the detailed description
All patients will receive standard medical care and no experimental interventions will be performed. The Pathfinder Overtube is already being used to assist in polyp removal at our center and many other centers, thus the device itself is not experimental. All patients scheduled to undergo ESD or EMR for colonic lesions at the Baylor St Luke's Medical Center as medically indicated and standard of care will be considered for the study. Patients for whom ESD or EMR is considered as part of their standard medical care will be offered to participate in this study. The patients involvement in the study does not preclude the use of the Pathfinder Overtube. If the patient does not agree to participate, outcomes related to the use of the Pathfinder Overtube or personal information will not be recorded. The Pathfinder Overtube will still be used to assist in the removal of polyps as deemed appropriate by the endoscopist. The physician performing the procedure will also discuss the study with the subjects and ask them to sign a consent. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided.
Data collection: After obtaining the informed consent, the following information will be collected from the subject's chart regarding the procedure:
1- Demographic information related to the study participants (age, sex, race, MRN etc.) 2- Comorbid conditions of the study participant (prior history of hysterectomy, or other abdominal surgeries) 3- Total en bloc resection rate. 4- Total E0 resection rate. 5- Total length of procedure time. 6- Total number of polyps detected, 7- Stabilization within the gastrointestinal lumen 8- Complications within 1 week after the procedure (perforation, bleeding) Equipment and techniques: All procedures will be performed with the Pathfinder Overtube (already FDA approved for use within the gastrointestinal lumen) and 19-inch high-definition monitor (OEV 191H; OlympusAmerica Inc.).
If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD or EMR with Pathfinder Overtube will be performed as medically indicated. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study. Data collection will last approximately 3 years.
- Conditions
- Gastrointestinal Polyps
- Being tested
- Endoscopic Submucosal Dissection with Pathfinder/Overtube device
- Keywords
- Endoscopic Submucosal Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal Dissection with Pathfinder/Overtube deviceProcedure or surgery
Removal of gastrointestinal polyps via ESD
| Study group | Role | What they receive |
|---|---|---|
| Research Subject | Only one group will be made which will contain all subjects recruited into research study. Receives: Procedure: Endoscopic Submucosal Dissection with Pathfinder/Overtube device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Defined by the completion of endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) procedure while utilizing the Rigidization Overtube.
Measured: Day 1
Procedure feasibility
Defined by the ability of endoscopist to reach lesion of interest while using the Rigidization Overtube for ESD/EMR procedures and complete entire procedure with device. This will be assessed as a rate (percentage).
Measured: Day 1
Secondary outcomes (3)
En bloc resection rate
En bloc resection rate using the Rigidization Overtube.
Measured: Day 1
R0 resection rate
To evaluate the R0 resection rates by assessing lesion margins while using the Rigidization Overtube.
Measured: 3-5 days
Procedure time
Determine overall procedure times using the Rigidizing Overtube.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start18 Oct 2021
- Primary completion30 Apr 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal PolypsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salmaan Azam Jawaid, MD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141032
- Sponsor's protocol ID
- H-49475
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Endoscopic Resection Procedures Performed With the Assistance of a Novel Rigidizing Overtube
- ClinicalTrials.gov ID
- NCT05141032
- Acronym / sponsor ID
- H-49475
- Conditions
- Gastrointestinal Polyps
- Keywords
- Endoscopic Submucosal Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 2 Dec 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.
This study collects information regarding your procedure. No changes will be done to your procedure and you are asked to consent for the use of your data in our database. You are being asked to be in this research study because you have a gastrointestinal lesion that needs to be removed. We remove these lesions endoscopically as part of the standard of care at Baylor St. Luke Medical Center, and we will be using a FDA approved device known as the Pathfinder Rigidization Overtube to assist with the removal of the polyp. This study is important because this is a relatively new procedure; although it is a part of your standard of care it is not done in many hospitals. We would like to document the outcomes and results of such procedures to continuously improve our standard of care.
Detailed description
All patients will receive standard medical care and no experimental interventions will be performed. The Pathfinder Overtube is already being used to assist in polyp removal at our center and many other centers, thus the device itself is not experimental. All patients scheduled to undergo ESD or EMR for colonic lesions at the Baylor St Luke's Medical Center as medically indicated and standard of care will be considered for the study. Patients for whom ESD or EMR is considered as part of their standard medical care will be offered to participate in this study. The patients involvement in the study does not preclude the use of the Pathfinder Overtube. If the patient does not agree to participate, outcomes related to the use of the Pathfinder Overtube or personal information will not be recorded. The Pathfinder Overtube will still be used to assist in the removal of polyps as deemed appropriate by the endoscopist. The physician performing the procedure will also discuss the study with the subjects and ask them to sign a consent. If the patient agrees to participate, he or she will be given the informed consent form and allowed enough time to read it. Opportunity to ask questions will be provided.
Data collection: After obtaining the informed consent, the following information will be collected from the subject's chart regarding the procedure:
1- Demographic information related to the study participants (age, sex, race, MRN etc.) 2- Comorbid conditions of the study participant (prior history of hysterectomy, or other abdominal surgeries) 3- Total en bloc resection rate. 4- Total E0 resection rate. 5- Total length of procedure time. 6- Total number of polyps detected, 7- Stabilization within the gastrointestinal lumen 8- Complications within 1 week after the procedure (perforation, bleeding) Equipment and techniques: All procedures will be performed with the Pathfinder Overtube (already FDA approved for use within the gastrointestinal lumen) and 19-inch high-definition monitor (OEV 191H; OlympusAmerica Inc.).
If the patient agrees to participate, he or she will sign the consent form and a copy will be provided. Data will be prospectively recorded according to the data collection form. ESD or EMR with Pathfinder Overtube will be performed as medically indicated. Follow-up will be carried out as medically indicated and no additional studies or clinic visits will be needed specifically for the purpose of this study. Data collection will last approximately 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Subject | – | Procedure: Endoscopic Submucosal Dissection with Pathfinder/Overtube deviceOnly one group will be made which will contain all subjects recruited into research study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been found to have duodenal or colon polyps will be identified as potential suitable subjects.
Key inclusion criteria (1 listed)
- Adult patients (18-80 years) Any gastrointestinal polyp that has been deemed appropriate for endoscopic removal.
Key exclusion criteria (3 listed)
- Pregnant patients
- Prisoners
- Unable to sign consent
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 |
|---|---|---|
| Endoscopic Submucosal Dissection with Pathfinder/Overtube deviceRemoval of gastrointestinal polyps via ESD | Procedure or surgery | Research Subject |
Primary outcome
Technical success
Time frame: Day 1
Defined by the completion of endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) procedure while utilizing the Rigidization Overtube.
Procedure feasibility
Time frame: Day 1
Defined by the ability of endoscopist to reach lesion of interest while using the Rigidization Overtube for ESD/EMR procedures and complete entire procedure with device. This will be assessed as a rate (percentage).
3 secondary outcomes
En bloc resection rate
Time frame: Day 1
R0 resection rate
Time frame: 3-5 days
Procedure time
Time frame: Day 1
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 15 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Polyps, run by Baylor College of Medicine 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 1 inclusion and 3 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 15 Feb 2024. 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?
Technical success (time frame: Day 1). 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 15 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.