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Pathfinder Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05141032
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Salmaan Azam Jawaid, Baylor College of Medicine

Brief 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. 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.

Condition or disease
Gastrointestinal Polyps

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Prospective Registry of Endoscopic Resection Procedures Performed With the Assistance of a Novel Rigidizing Overtube
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : December 30, 2022

Group/Cohort
Research Subject
Only one group will be made which will contain all subjects recruited into research study.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. En bloc resection rate [ Time Frame: Day 1 ]
    En bloc resection rate using the Rigidization Overtube.

  2. R0 resection rate [ Time Frame: 3-5 days ]
    To evaluate the R0 resection rates by assessing lesion margins while using the Rigidization Overtube.

  3. Procedure time [ Time Frame: Day 1 ]
    Determine overall procedure times using the Rigidizing Overtube.


Other Outcome Measures:
  1. Complications [ Time Frame: 2 weeks ]
    Issues arising immediately or post-procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have been found to have duodenal or colon polyps will be identified as potential suitable subjects.
Criteria

Inclusion Criteria:

  • Adult patients (18-80 years) Any gastrointestinal polyp that has been deemed appropriate for endoscopic removal.

Exclusion Criteria:

  • Pregnant patients
  • Prisoners
  • Unable to sign consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05141032


Contacts
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Contact: Michael Mercado 713-798-3606 Michael.Mercado@bcm.edu
Contact: Valeria Pena Munoz 713-798-2308 Sylvia.PenaMunoz@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Michael Mercado    713-798-3606    Michael.Mercado@bcm.edu   
Contact: Salmaan Jawaid, MD    713-798-0950    Salmaan.Jawaid@bcm.edu   
Principal Investigator: Salmaan Jawaid, MD         
Sub-Investigator: Mohamed Othman, MD         
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Salmaan Azam Jawaid, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05141032    
Other Study ID Numbers: H-49475
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Salmaan Azam Jawaid, Baylor College of Medicine:
Endoscopic Submucosal Dissection