Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03518905
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2018-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004935', 'term': 'Esophageal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D004945', 'term': 'Esophagoscopy'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients are blinded either to sham or treatment and unblinded after 24 weeks after final examination'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized sham-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2018-04-15', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normalization of the Reflux Symptom Index', 'timeFrame': '6 months after first RFA treatment/or sham procedure', 'description': 'Normalization of the Reflux Symptom Index (RSI \\<14) after two treatment/sham sessions evaluated 3 months after the second (sham-) treatment (therefore 6 months after the first endoscopy with/without RFA). Proton-pump inhibitors are paused 8 weeks before assessment'}], 'secondaryOutcomes': [{'measure': 'Histological eradication rate after radiofrequency ablation or sham treatment', 'timeFrame': '6 months after first RFA treatment/or sham procedure', 'description': 'Histologic eradication rate after RFA treatment/sham procedure measured after finalization of RFA (normalization of Reflux Symptom Index/or a maximum of two treatment sessions) or at the time of second sham treatment.'}, {'measure': 'SF-12 quality of life', 'timeFrame': 'At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment'}, {'measure': 'Reflux Finding Score', 'timeFrame': 'Evaluated at the first intervention at study completion after 6 months', 'description': 'the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux. The reflux finding score (RFS) represents an objective and validated instrument to analyze physical findings and severity of laryngopharyngeal reflux. An 8-item checklist with excellent inter-observer reliability grades abnormalities documented during laryngoscopy from 0-26 points. The total score is reported and summed from an 8 item checklist providing 0-4 points. Statistically, total scores greater than 7 have a likelihood of 95% to reflect LPR. Higher scores represent worse outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophagus Disorder']}, 'descriptionModule': {'briefSummary': 'The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological proven presence of heterotopic gastric mucosa,\n* pathologic Reflux Symptom Index (\\>25)\n* age: 18-70\n* presence of symptoms \\> 6 months,\n* no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment\n* negative symptom correlation for symptoms with reflux events in ambulatory pH monitoring\n\nExclusion Criteria:\n\n* Not willing to participate in this study\n* pregnancy\n* lactation period'}, 'identificationModule': {'nctId': 'NCT03518905', 'acronym': 'RAGE', 'briefTitle': 'Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa - a Prospective Randomized Sham-controlled Trial - the RAGE Study', 'orgStudyIdInfo': {'id': '1340/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'sham-treatment', 'description': 'Patients with symptomatic large heterotopic gastric mucosa receive an esophagoscopy without radiofrequency ablation under sedation', 'interventionNames': ['Procedure: esophagoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'treatment arm', 'description': 'Patients with symptomatic large hetertotopic gastric mucosa receive an esophagoscopy with radiofrequency ablation (12J/cm2) using the Barrx channel RFA endoscopic catheter (Medtronic)', 'interventionNames': ['Device: Radiofrequency ablation']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'DEVICE', 'description': 'Radiofrequency ablation is performed using the Barrx Channel endoscopic catheter (Medtronic, Dublin, Republic of Ireland) generating an energy density level of 12 Joule/cm2. The energy is applied using a simplified protocol of three ablations without removal of coagulated tissue. The device is used on a routinely basis all around the world and already approved. The ablation catheter is applied through the working channel of the endoscope.', 'armGroupLabels': ['treatment arm']}, {'name': 'esophagoscopy', 'type': 'PROCEDURE', 'description': 'Patients receive an esophagoscopy without radiofrequency ablation under sedation', 'armGroupLabels': ['sham-treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ivan Kristo, MD', 'role': 'CONTACT', 'email': 'ivan.kristo@meduniwien.ac.at', 'phone': '+434040056210'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Ivan Kristo, MD', 'role': 'CONTACT', 'email': 'ivan.kristo@meduniwien.ac.at', 'phone': '+43140 40056210'}, {'name': 'Sebastian Schoppmann, MD', 'role': 'CONTACT', 'email': 'sebastian.schoppmann@meduniwien.ac.at', 'phone': '+43140 40056210'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Attending surgeon, Vize-Chair of the esophageal functional testing laboratory', 'investigatorFullName': 'Dr. Ivan Kristo', 'investigatorAffiliation': 'Medical University of Vienna'}}}}