[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723937":3,"trial-entities:NCT07723937":97,"trial-summary:NCT07723937":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":43,"minimum_age":44,"maximum_age":24,"healthy_volunteers":15,"eligibility_criteria":45,"std_ages":62,"locations":65,"central_contacts":89,"overall_officials":92,"references":95,"see_also_links":96},"NCT07723937","H-59028","GelPOINT® Path-Assisted Endoscopic Removal of Colon and Rectal Polyps: A Feasibility and Safety Study","GelPOINT® Path-Assisted Endoscopic Submucosal Dissection for Colorectal Polyps: A Feasibility and Safety Study","RECRUITING","2027-04-30","2026-04","2026-07-23","2026-05-19","Baylor College of Medicine","OTHER",false,"This prospective, single-center, observational feasibility and safety study will evaluate the use of the GelPOINT® Path transanal access platform during endoscopic submucosal dissection (ESD) for the removal of colorectal polyps. The GelPOINT® Path system is designed to improve access, maintain stable insufflation, and enhance visualization during advanced endoscopic procedures.\n\nThe study will enroll adult patients undergoing ESD for eligible colorectal lesions. The primary objective is to evaluate the technical feasibility, procedural performance, and safety of GelPOINT® Path-assisted ESD. Procedural outcomes, including procedure speed, technical success, resection outcomes, and procedure-related adverse events, will be collected prospectively. Participants will receive standard clinical care and will be followed for approximately 4 weeks after the procedure to assess delayed adverse events.","Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique that enables en bloc removal of large or complex colorectal lesions while preserving the bowel and reducing the need for surgical resection. Despite its advantages, colorectal ESD remains technically demanding because of limited visualization, unstable luminal distension, and restricted instrument maneuverability, particularly in the distal colon and rectum.\n\nThe GelPOINT® Path transanal access platform has been widely used in transanal minimally invasive surgery (TAMIS) to provide stable insufflation and improved access for rectal procedures. This study will evaluate whether incorporating the GelPOINT® Path platform into colorectal ESD can improve procedural efficiency while maintaining the safety and effectiveness of standard ESD.\n\nThis is a prospective, single-center, observational feasibility and safety study enrolling approximately 30 adult patients undergoing ESD for eligible colorectal lesions. All procedures will be performed by experienced advanced endoscopists as part of routine clinical care. The use of the GelPOINT® Path platform will be determined by the treating physician according to standard clinical practice. No experimental therapeutic interventions or deviations from routine clinical management will occur.\n\nClinical, procedural, pathological, and follow-up data will be collected prospectively using standardized case report forms. Outcomes will include technical success, procedure time, dissection speed, en bloc resection, R0 resection, curative resection, device performance, operator workload, and intraprocedural and delayed adverse events. Participants will be followed for approximately 4 weeks after the procedure to evaluate post-procedural safety.\n\nThe findings from this study are expected to provide important feasibility and safety data regarding the use of the GelPOINT® Path platform as an adjunct to colorectal ESD and may help guide the design of future comparative studies evaluating its clinical effectiveness.",[19,20,21],"Polyp Colorectal","Rectal Adenoma","Adenoma Colon Polyp",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},30,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"Procedure Speed","Procedure speed, calculated as lesion surface area (cm²) divided by total procedure time (hours), to evaluate the technical performance of GelPOINT® Path-assisted endoscopic submucosal dissection.","During the index procedure",[36,39],{"measure":37,"description":38,"timeFrame":34},"En Bloc Resection Rate","Percentage of lesions resected en bloc (in a single piece).",{"measure":40,"description":41,"timeFrame":42},"Complete (R0) Resection Rate","Percentage of lesions with histologically negative lateral and vertical margins following resection.","Pathology assessment following the index procedure (within approximately 2 weeks)","ALL","18 Years",{"inclusion":46,"exclusion":55,"raw_text":61},[47,48,49,50,51,52,53,54],"Adults aged 18 years or older.","Able and willing to provide written informed consent.","Colorectal polyps located in the transverse colon, descending colon, rectosigmoid colon, or rectum (rectal lesions located at least 2 cm from the anal verge).","Referred for endoscopic submucosal dissection (ESD) of colorectal neoplastic lesions meeting at least one of the following criteria:","Lesions with prior resection or scarring proximal to the sigmoid colon.","Granular lateral spreading tumors (GLST) \\>30 mm.","Non-granular lateral spreading tumors (NGLST) \\>20 mm.","Lesions with suspected submucosal invasion, including Paris classification IIa+IIc lesions or lesions with a positive non-lifting sign",[56,57,58,59,60],"Younger than 18 years of age.","Unable or unwilling to provide informed consent.","Pregnant.","Pedunculated lesions (Paris classification Ip or Isp).","Lesions involving the appendix or ileocecal valve","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Able and willing to provide written informed consent.\n* Colorectal polyps located in the transverse colon, descending colon, rectosigmoid colon, or rectum (rectal lesions located at least 2 cm from the anal verge).\n* Referred for endoscopic submucosal dissection (ESD) of colorectal neoplastic lesions meeting at least one of the following criteria:\n* Lesions with prior resection or scarring proximal to the sigmoid colon.\n* Granular lateral spreading tumors (GLST) \\>30 mm.\n* Non-granular lateral spreading tumors (NGLST) \\>20 mm.\n* Lesions with suspected submucosal invasion, including Paris classification IIa+IIc lesions or lesions with a positive non-lifting sign\n\nExclusion Criteria:\n\n* Younger than 18 years of age.\n* Unable or unwilling to provide informed consent.\n* Pregnant.\n* Pedunculated lesions (Paris classification Ip or Isp).\n* Lesions involving the appendix or ileocecal valve",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":13,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":86},"Houston","Texas","77030","United States",[72,77,81,84],{"name":73,"role":74,"phone":75,"email":76},"Tara A Keihanian, MD","CONTACT","631-800-4142","Tara.Keihanian@bcm.edu",{"name":78,"role":74,"phone":79,"email":80},"Haydee Rochits Cueto","713-798-3606","Haydee.RochitsCueto@bcm.edu",{"name":82,"role":83},"Mohamed Othman, MD","SUB_INVESTIGATOR",{"name":85,"role":83},"Fares Ayoub, MD",{"lat":87,"lon":88},29.76328,-95.36327,[90],{"name":91,"role":74,"phone":75,"email":76},"Tara Keihanian, MD",[93],{"name":91,"affiliation":13,"role":94},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Colorectal Polyp",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an observational study, meaning doctors will watch and record information during your routine procedure. It will include about 30 adult participants at a single medical center.","completed","GelPOINT® Path for Colorectal Polyp Removal","This study is looking at how well a device called GelPOINT® Path works when removing large or complex colon and rectal polyps (growths) using a procedure called endoscopic submucosal dissection (ESD). ESD is a way to remove polyps without major surgery. The GelPOINT® Path system helps doctors see better and work more easily during the procedure. We want to see if using GelPOINT® Path makes the ESD procedure faster and just as safe as standard ESD. This study is for adults aged 18 or older who need ESD for certain colorectal polyps. We plan to include about 30 people. The main goal is to see how quickly the procedure can be done.","The primary outcome, procedure speed, will be measured during the procedure itself. No further follow-up is specified.",112,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]