Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT05618392
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2022-06-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'abdominal pain', 'timeFrame': '7 days', 'description': 'numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."'}, {'measure': 'predictive factors', 'timeFrame': 'DAY 1', 'description': 'determine predictive factors of pain suspected in advance:\n\n* Fasting anterior stomach wall depth estimated during the ultrasound survey(mm)\n* Gastric topography determined under X-ray (subcostal / partially retrohepatic)\n* Topography of the anchors: large tuberosity / antrum\n* Distance of anchors from each other (mm)\n* Depth of the anchors (mm)\n* Skin depression of anchors: (with depression, without depression)\n* Intraparietal length of the gastrostomy tube (mm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrostomy Complications', 'Gastrostomy']}, 'descriptionModule': {'briefSummary': 'A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG).\n\nThe primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.', 'detailedDescription': 'PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG).\n\nAbdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment.\n\nThe primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement.\n\nThe secondary objective is to evaluate predictive factors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients needing a Percutaneous radiologic Gastrostomy under local anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Needing a radiologic gastrostomy under local anesthesia\n* Age ≥ 18 years old\n* Read, write and understand the French language\n\nExclusion Criteria:\n\n* Patient under guardianship, deprived of liberty, safeguard of justice\n* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)\n* Refusal to participate in research'}, 'identificationModule': {'nctId': 'NCT05618392', 'acronym': 'DOULEURGPR', 'briefTitle': 'Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Valence'}, 'officialTitle': 'Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors', 'orgStudyIdInfo': {'id': 'RIPH-CHV-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single group assignment', 'description': 'only one arm. Each patient complete numerical scale questionnaire (0-10)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26400', 'city': 'Valence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'sandrine Beauchard, MD', 'role': 'CONTACT', 'email': 'sbeauchard@ch-valence.fr', 'phone': '+33475818870'}], 'facility': 'Sandrine Beauchard', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}], 'centralContacts': [{'name': 'Mathilde FINOT, MD', 'role': 'CONTACT', 'email': 'mfinot@ch-valence.fr', 'phone': '+33475818870'}, {'name': 'Guillaume BUIRET, MD', 'role': 'CONTACT', 'email': 'gbuiret@ch-valence.fr', 'phone': '+33475818870'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Valence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}