Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-01 @ 9:09 AM
Study NCT ID:
NCT06099392
Status:
UNKNOWN
Last Update Posted:
2023-10-25
First Post:
2023-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Transcutaneous Electrical Acustimulation on Small Bowel Preparation for Capsule Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-07-16', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of "adequate" cleansing of the small intestine', 'timeFrame': 'one year', 'description': 'The rate of "adequate" cleansing of the small intestine'}], 'secondaryOutcomes': [{'measure': 'Diagnostic rate of video capsule endoscopy', 'timeFrame': 'one year', 'description': 'Diagnostic rate of video capsule endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Small Bowel Preparation']}, 'descriptionModule': {'briefSummary': 'Transcutaneous elctroacupuncture(TEA) at ST36 can improve gastrointestinal motility. Therefore,the investigators hypothesized that if TEA is applied to the preparation of small bowel capsule endoscopy, the small bowel peristalsis of patients can be regulated by electrical stimulation at (ST36). On the one hand, it can be used in combination with compound polyethylene glycol electrolyte powder, which is conducive to the discharge of small bowel contents and improve the imaging quality. On the other hand, it can improve the diagnostic rate by adjusting the intestinal transit time, And the completion rate of the examination can be improved by accelerating the gastric emptying time of capsule endoscopy.\n\nTherefore, in order to explore the effect of TEA stimulation at ST36 combined with polyethylene glycol powder on preparation for small bowel capsule endoscopy, the investigators designed this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAgree to sign an informed consent form; Aged 18 to 75 years old Plan to undergo small bowel capsule endoscopy;\n\nExclusion Criteria:\n\nClinical diagnosis of gastrointestinal stricture, bowel obstruction, gastrointestinal fistula, intestinal resection; Clinical diagnosis of dysphagia; Those who require fasting or parenteral nutrition support treatment; Individuals with gastrointestinal motility disorders; Oral administration of gastrointestinal motility drugs within 1 week; Implanting medical electronic devices; Those who are allergic to compound polyethylene glycol electrolyte powder and dimethicone oil and cannot tolerate oral laxatives for intestinal preparation; Skin diseases that affect electrode fixation; Pregnant, preparing to conceive, or breastfeeding patients; Familiar with acupuncture and moxibustion treatment, acupoint selection or meridians; Researchers believe that it is not suitable for participants.'}, 'identificationModule': {'nctId': 'NCT06099392', 'briefTitle': 'The Effect of Transcutaneous Electrical Acustimulation on Small Bowel Preparation for Capsule Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'The Effect of Transcutaneous Electrical Acustimulation Combined With Polyethylene Glycol-electrolyte on the Quality of Small Bowel Preparation for Capsule Endoscopy', 'orgStudyIdInfo': {'id': 'CZXH202301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEA group', 'description': 'TEA at ST36 (Zusanli) combined with 2L Polyethylene Glycol Electrolytes Powder for bowel preparation', 'interventionNames': ['Device: digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)']}, {'type': 'NO_INTERVENTION', 'label': 'Sham-TEA group', 'description': '2L Polyethylene Glycol Electrolytes Powder for bowel preparation'}], 'interventions': [{'name': 'digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)', 'type': 'DEVICE', 'description': 'TEA at Zusanli(ST 36) 45 min when drinking Polyethylene Glycol Electrolytes Powder', 'armGroupLabels': ['TEA group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei-Fen Xie, MD. PhD', 'role': 'CONTACT', 'email': 'weifenxie@medmail.com.cn', 'phone': '(86) 21 81886824.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of gastroenterology, Shanghai Changzheng Hospital', 'investigatorFullName': 'Wei-Fen Xie', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}