Pathfinder Registry
Condition: Gastrointestinal Polyps
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): Endoscopic Submucosal Dissection with Pathfinder/Overtube device
Intervention type(s): Procedure
Intervention description(s): Removal of gastrointestinal polyps via ESD
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Endoscopic Submucosal Dissection