Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-02 @ 9:21 AM
Study NCT ID:
NCT07060495
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RADA16 for Adult Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'From enrollment to post-operative day fifteen', 'description': 'Pain assessed via the pain visual analog scale (VAS). The primary outcome measure will be assessed via online survey on post-operative day one then subsequently every other day until post-operative day fifteen.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with post-tonsillectomy hemorrhage who receive topical agents', 'timeFrame': 'From enrollment to post-operative day fifteen', 'description': 'Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage'}, {'measure': 'Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room', 'timeFrame': 'From enrollment to post-operative day fifteen', 'description': 'Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage'}, {'measure': 'Number of participants who require hospital readmission for post tonsillectomy hemorrhage management', 'timeFrame': 'From enrollment to post-operative day fifteen', 'description': 'Number of participants who require readmission for management of post tonsillectomy hemorrhage'}, {'measure': 'Number of participants who require a rescue analgesic for management following tonsillectomy procedure', 'timeFrame': 'From enrollment to post-operative day fifteen', 'description': 'Number of participants who use a rescue analgesic following their tonsillectomy procedure'}, {'measure': 'Days participants take to resume their regular diet post operation', 'timeFrame': 'From enrollment to post-operative day fifteen', 'description': 'Recording how many days it takes for participants to return to their regular diet post operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['tonsillectomy', 'hemostasis', 'postop complications'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '28828761', 'type': 'BACKGROUND', 'citation': 'Pynnonen M, Brinkmeier JV, Thorne MC, Chong LY, Burton MJ. Coblation versus other surgical techniques for tonsillectomy. Cochrane Database Syst Rev. 2017 Aug 22;8(8):CD004619. doi: 10.1002/14651858.CD004619.pub3.'}, {'pmid': '23392233', 'type': 'BACKGROUND', 'citation': 'Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.'}, {'pmid': '30798778', 'type': 'BACKGROUND', 'citation': 'Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures.\n\nResearchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.\n\nParticipants will:\n\n* Undergo tonsillectomy procedure.\n* Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.', 'detailedDescription': 'This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain, bleeding, readmission, and use of a rescue analgesic (ex., oxycodone). We propose a randomized controlled trial whereby patients undergoing tonsillectomy would either receive a standard analgesic regimen (postoperative acetaminophen and NSAIDs plus oxycodone as a supplemental analgesic) versus intraoperative RADA16 application plus a standard analgesic regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAdults undergoing tonsillectomy (CPT codes)\n\nExclusion criteria:\n\nPatients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy\n\nPatients who have had prior tonsillectomy or tonsillotomy\n\nPatient undergoing tonsillectomy with concern for malignancy\n\nPatients who are on opioids chronically prior to surgery\n\nPatients with an additional indication for pain management (i.e. unrelated to tonsillectomy)\n\nPatients who have been diagnosed with a bleeding disorder or hematologic malignancy\n\nPatients who are on anticoagulants\n\nThe following at-risk populations:\n\nAnyone under age 18\n\nPregnant women\n\nPrisoners\n\nAdults unable to consent (anyone lacking capacity)'}, 'identificationModule': {'nctId': 'NCT07060495', 'briefTitle': 'RADA16 for Adult Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries', 'orgStudyIdInfo': {'id': 'Pro2024001000'}, 'secondaryIdInfos': [{'id': 'FP00039655', 'type': 'OTHER_GRANT', 'domain': '3-D Matrix'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RADA16', 'description': 'Patients randomized to the treatment arm will undergo application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.', 'interventionNames': ['Device: RADA16 hydrogel']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.'}], 'interventions': [{'name': 'RADA16 hydrogel', 'type': 'DEVICE', 'otherNames': ['puragel'], 'description': 'Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.', 'armGroupLabels': ['RADA16']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabriel Frimpong, MPH, PA', 'role': 'CONTACT', 'email': 'gf345@njms.rutgers.edu', 'phone': '973-972-2309'}, {'name': 'Wayne Hsueh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cooperman Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabriel Frimpong, MPH, PA', 'role': 'CONTACT', 'email': 'gf345@njms.rutgers.edu', 'phone': '9739722548'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'centralContacts': [{'name': 'Wayne D Hsueh, MD', 'role': 'CONTACT', 'email': 'wayne.hsueh@rutgers.edu', 'phone': '973-972-4588'}, {'name': 'Emily Kwon, BA', 'role': 'CONTACT', 'email': 'esk104@njms.rutgers.edu'}], 'overallOfficials': [{'name': 'Wayne D Hsueh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Determining if access to university data can be available for the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOC PROF-CLIN', 'investigatorFullName': 'Wayne Daniel Hsueh, MD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}