Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:48 AM
Study NCT ID:
NCT07368361
Status:
RECRUITING
Last Update Posted:
2026-01-26
First Post:
2025-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Th Study Wants to Compare the Best Technique for Sinus Operation in CRSWNP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This randomized controlled trial aims to compare the efficacy and safety of reboot surgery versus conventional full house FESS in patients with refractory CRSwNP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2025-12-25', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Comparative Outcomes of Mucosal Reset (Reboot) Versus Complete Sinusotomy (Full House FESS) in CRSwNP: A Prospective Study', 'timeFrame': '1-1-2027', 'description': '24-month recurrence rates (defined as endoscopic polyp score ≥2)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['REBOOT, SINUSOTOMY, FULL HOUSE FESS, CRSWNP'], 'conditions': ['CRSWNP']}, 'referencesModule': {'references': [{'pmid': '32077450', 'type': 'RESULT', 'citation': "Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600."}, {'pmid': '30663058', 'type': 'RESULT', 'citation': 'Alsharif S, Jonstam K, van Zele T, Gevaert P, Holtappels G, Bachert C. Endoscopic Sinus Surgery for Type-2 CRS wNP: An Endotype-Based Retrospective Study. Laryngoscope. 2019 Jun;129(6):1286-1292. doi: 10.1002/lary.27815. Epub 2019 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to compare the efficacy and safety of reboot surgery versus conventional full house FESS in patients with refractory CRSwNP, focusing on:\n\n1\\. Primary Outcome:\n\n* Compare 24-month recurrence rates (defined as endoscopic polyp score ≥2) 2. Secondary Outcomes:\n* Recurrence-free survival (time to first recurrence), Quality of life improvement (SNOT-22 scores), Reduction in systemic corticosteroid use, Complication rates (synechiae, bleeding, infection) and Cost-effectiveness of each approach', 'detailedDescription': 'Chronic Rhinosinusitis (CRS) affects 5-15% of people globallymmmmm. Traditionally classified as with polyps (CRSwNP) or without (CRSsNP), modern approaches now focus on endotype-based categorization.CRSwNP, linked to type-2 inflammation\\[4\\], often causes severe, recurrent symptoms that significantly impair quality of life and increase healthcare costs.\\[5\\] Despite this, its impact is frequently underestimated, leading to improper treatment-such as overuse of oral steroids-which risks long-term side effects.\n\nEffective control often requires multimodal therapy, yet results remain inconsistent. Recently, monoclonal antibodies (mAbs) targeting type-2 inflammation have revolutionized treatment, offering long-term relief and addressing comorbidities.\n\nDespite these advances, surgery-particularly endoscopic sinus surgery (ESS)-remains pivotal, especially as initial therapy. ESS continues to evolve, balancing effectiveness, invasiveness, and cost.\n\nFor refractory CRSwNP with rapid post-surgery recurrence, repeated interventions are often needed. Recent strategies like the "reboot approach"-complete removal of inflamed sinus mucosa down to the bone-aim to reset the inflammatory environment and promote healthier mucosal regeneration (Alsharif et al.) .\n\nThe aim here is to demonstrate how effectiveness of "Reboot surgery: for chronic sinusitis with polyps reduces recurrences, extends symptom-free periods, improves quality of life, and decreases steroid use. We analyze its benefits and limitations based on type 2 inflammation mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Patients above the age of 18 years presenting with recurrent refractory CRSwNP (failed ≥1 biologic/prior FESS), Type-2 endotype confirmation (blood/tissue eosinophilia, IgE ≥100 IU/mL), Lund-Mackay CT score ≥10 will be included in the study.\n\nExclusion Criteria:\n\neosinophilic granulomatosis with polyangiitis (EGPA) or severe systemic diseases (except controlled asthma or NSAID-exacerbated respiratory disease), neoplasms, vasoconstrictor abuse (e.g., oxymetazoline dependence), unilateral nasal inflammatory disease, bilateral inflammatory disease without polyps, or treatment with monoclonal antibodies in the past 12 months, Patients younger than 18 years of age and patients are unfit for general anesthesia.'}, 'identificationModule': {'nctId': 'NCT07368361', 'acronym': 'REBOOT', 'briefTitle': 'Th Study Wants to Compare the Best Technique for Sinus Operation in CRSWNP', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': '"Comparative Outcomes of Mucosal Reset (Reboot) Versus Complete Sinusotomy (Full House FESS) in CRSwNP: A Prospective Study', 'orgStudyIdInfo': {'id': 'KFSIRB200-710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNP', 'description': 'The first group will undergo Reboot operation" Complete removal of inflamed mucosa to periosteum"', 'interventionNames': ['Device: Reboot operation" Complete removal of inflamed mucosa to periosteum"']}, {'type': 'EXPERIMENTAL', 'label': 'Complete Sinusotomy (Full House FESS IN CRSWNP', 'description': 'the second group will have a conventional FESS operation " Mucosal preservation where healthy"', 'interventionNames': ['Device: endoscopic nasal operation']}], 'interventions': [{'name': 'endoscopic nasal operation', 'type': 'DEVICE', 'description': '. conventional FESS operation "', 'armGroupLabels': ['Complete Sinusotomy (Full House FESS IN CRSWNP']}, {'name': 'Reboot operation" Complete removal of inflamed mucosa to periosteum"', 'type': 'DEVICE', 'description': 'Reboot operation" Complete removal of inflamed mucosa to periosteum"', 'armGroupLabels': ['"Comparative Outcomes of Mucosal Reset (Reboot) IN CRSWNP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33155.', 'city': 'Egypt', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'role': 'CONTACT', 'phone': '0473109517'}], 'facility': 'Kafrelsheikh Faculty of Medicine', 'geoPoint': {'lat': 44.27004, 'lon': -79.3046}}], 'centralContacts': [{'name': 'Amr Maher Shady Kafr Elsheikh Hospital University, Doctor', 'role': 'CONTACT', 'email': 'amrshady00@gmail.com', 'phone': '0201060485163'}, {'name': 'Saad Elzayat Kafr Elsheikh Hospital University, professor', 'role': 'CONTACT', 'email': 'saad_hilmy@med.kfs.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Amr Mahr Shady', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}