Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT03654066
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-20
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botox or Botox With Esophageal Dilation in Patients With Achalasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000071066', 'term': 'Patient Reported Outcome Measures'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D063868', 'term': 'Patient Outcome Assessment'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dysphagia score', 'timeFrame': '12 months', 'description': 'Dysphagia score as measured by patient reported outcomes will be used to compare the two groups. The scale runs from 0 (no symptoms) to 100 (severe symptoms).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Achalasia']}, 'descriptionModule': {'briefSummary': 'Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM\n* Patient undergoing routine care upper endoscopy for achalasia\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Previous surgery for reflux or peptic ulcer disease\n* Significant medical conditions possibly placing subjects at risk to undergo endoscopy'}, 'identificationModule': {'nctId': 'NCT03654066', 'briefTitle': 'Botox or Botox With Esophageal Dilation in Patients With Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia', 'orgStudyIdInfo': {'id': '181420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum toxin', 'description': 'A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation.', 'interventionNames': ['Drug: Botulinum toxin type A', 'Other: Patient reported outcomes', 'Diagnostic Test: Barium esophagram']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum toxin and dilation', 'description': 'A one time dose of Botulinum toxin (Botox) is injected into the muscle of the LES leading to blockage of acetylcholine release from nerve endings resulting in increased relaxation. Subjects will also undergo distal esophageal dilation using a 20mm through the scope balloon positioned across the LES.', 'interventionNames': ['Drug: Botulinum toxin type A', 'Device: Endoscope balloon dilator', 'Other: Patient reported outcomes', 'Diagnostic Test: Barium esophagram']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': 'Botox injection in the LES', 'armGroupLabels': ['Botulinum toxin', 'Botulinum toxin and dilation']}, {'name': 'Endoscope balloon dilator', 'type': 'DEVICE', 'description': 'Distal esophageal dilation', 'armGroupLabels': ['Botulinum toxin and dilation']}, {'name': 'Patient reported outcomes', 'type': 'OTHER', 'description': 'Subjects will complete two patient reported outcome measures (Eckardt and MADS).', 'armGroupLabels': ['Botulinum toxin', 'Botulinum toxin and dilation']}, {'name': 'Barium esophagram', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium', 'armGroupLabels': ['Botulinum toxin', 'Botulinum toxin and dilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center Endoscopy Laboratory', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Dhyanesh Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dhyanesh Patel', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}