Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-27 @ 1:23 AM
Study NCT ID:
NCT06189859
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Allocation of patients will be in sealed envelopes to be opened on day of the procedure. The investigator and care provider (same) will thus be unmasked. Participant and outcomes assessor will remain masked until the end of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of endoscopic submucosal dissection', 'timeFrame': 'during the procedure', 'description': 'Speed of dissection (cm/minute)'}], 'secondaryOutcomes': [{'measure': 'Intraprocedural Bleeding', 'timeFrame': 'during the procedure', 'description': 'Bleeding necessitating change in electrosurgical mode'}, {'measure': 'Significant Intraprocedural bleeding', 'timeFrame': 'during the procedure', 'description': 'Bleeding necessitating change of instrument to coagulating forceps'}, {'measure': 'Other Adverse events', 'timeFrame': 'during the procedure', 'description': 'Including mucosal injury, postoperative pain, postoperative bleeding and other complications'}, {'measure': 'Total procedure duration', 'timeFrame': 'during the procedure', 'description': 'Total procedure duration'}, {'measure': 'Endoscopic submucosal tunneling duration', 'timeFrame': 'during the procedure', 'description': 'Endoscopic submucosal tunneling duration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['achalasia', 'POEM', 'ELECTROSURGERY', 'SPRAY COAGULATION', 'PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY'], 'conditions': ['Achalasia', 'Achalasia Cardia']}, 'descriptionModule': {'briefSummary': 'Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing POEM procedure for any esophageal motility disorder\n* Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy\n\nExclusion Criteria:\n\n* Esophageal varices\n* Esophageal neoplasms\n* Non-correctable coagulopathy\n* Failure to provide an informed consent'}, 'identificationModule': {'nctId': 'NCT06189859', 'briefTitle': 'Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ESRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spray coag mode', 'description': 'After initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5)', 'interventionNames': ['Procedure: endoscopic submucosal dissection using SPRAY COAG mode']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Precisect mode', 'description': 'After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5)', 'interventionNames': ['Procedure: endoscopic submucosal dissection using Precisect mode']}], 'interventions': [{'name': 'endoscopic submucosal dissection using SPRAY COAG mode', 'type': 'PROCEDURE', 'otherNames': ['POEM'], 'description': 'After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Spray coag mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection', 'armGroupLabels': ['Spray coag mode']}, {'name': 'endoscopic submucosal dissection using Precisect mode', 'type': 'PROCEDURE', 'description': 'After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Precisect mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection', 'armGroupLabels': ['Precisect mode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hany M Shehab, MD', 'role': 'CONTACT', 'email': 'H.shehab@kasralainy.edu.eg', 'phone': '01111111071'}, {'name': 'Hany M Shehab, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'hany Shehab, MD, FRCP', 'role': 'CONTACT', 'email': 'h.shehab@kasralainy.edu.eg', 'phone': '+201111111071'}], 'overallOfficials': [{'name': 'hany shehab', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hany Shehab', 'investigatorAffiliation': 'Cairo University'}}}}