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OpenTrials
Completed

NCT Number: NCT05141032

Pathfinder Registry

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.

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Key information

Conditions

Gastrointestinal Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Submucosal Dissection with Pathfinder/Overtube device

Procedure

Removal of gastrointestinal polyps via ESD

Primary outcomes

  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 and complete entire procedure with device. This will be assessed as a rate (percentage).

Secondary outcomes

  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 outcomes

  1. Complications

    Time frame: 2 weeks

    Issues arising immediately or post-procedure

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Prospective Registry of Endoscopic Resection Procedures Performed With the Assistance of a Novel Rigidizing Overtube

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2021
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.