Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06798935
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2025-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012006', 'term': 'Rectovaginal Fistula'}], 'ancestors': [{'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014624', 'term': 'Vaginal Fistula'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-18', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patietns with feasible PRS injection', 'timeFrame': '1 day (day of surgery)', 'description': 'Feasibility was assessed by the ability to successfully obtain SVF and PRP and to inject the combined product (i.e. PRS) during the procedure.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with safe PRS injection', 'timeFrame': '30 days postoperatively', 'description': 'Safety was assessed by documenting the number of (serious) adverse events related to PRS injection within 30 days postoperatively. In addition, we report on number of serious fistula-related emergency room (ER) visits and number of readmissions within 30 days postoperatively.'}, {'measure': 'Number of patients with clinical closure', 'timeFrame': '12 months', 'description': 'closure of the vaginal fistula opening without complaints of discharge at physical examination'}, {'measure': 'Number of re-interventions', 'timeFrame': '12 months', 'description': ') the need for unplanned re-interventions due to residual clinical and/or radiological fistulizing disease or recurrent disease'}, {'measure': 'Number of patients with radiological healing', 'timeFrame': '12 months', 'description': 'radiological healing or radiological improvement, based on available MRI reports'}, {'measure': 'Number of patients with recurrence', 'timeFrame': '12 months', 'description': 'the reopening of the vaginal fistula opening after clinical closure and/or radiological healing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectovaginal fistula', 'anovaginal fistula', 'platelet-rich stroma', 'stromal vascular fraction', 'platelet-rich plasma', 'autologous', 'cell therapy'], 'conditions': ['Rectovaginal Fistula', 'Anovaginal Fistula']}, 'referencesModule': {'references': [{'pmid': '32384409', 'type': 'BACKGROUND', 'citation': 'Deijl W, Arkenbosch J, van Ruler O, van der Woude CJ, Stevens HPJD, de Graaf E, Schouten R. Autologous Platelet-Rich Stroma in Complex Perianal Fistulas. Dis Colon Rectum. 2020 Jun;63(6):860-861. doi: 10.1097/DCR.0000000000001546. No abstract available.'}, {'pmid': '34606026', 'type': 'BACKGROUND', 'citation': 'Schouten WR, Arkenbosch JHC, van der Woude CJ, de Vries AC, Stevens HP, Fuhler GM, Dwarkasing RS, van Ruler O, de Graaf EJR. Efficacy and safety of autologous adipose-derived stromal vascular fraction enriched with platelet-rich plasma in flap repair of transsphincteric cryptoglandular fistulas. Tech Coloproctol. 2021 Dec;25(12):1301-1309. doi: 10.1007/s10151-021-02524-6. Epub 2021 Oct 4.'}, {'pmid': '36571818', 'type': 'BACKGROUND', 'citation': "Arkenbosch JHC, van Ruler O, Dwarkasing RS, Fuhler GM, Schouten WR, van Oud-Alblas MB, de Graaf EJR, de Vries AC, van der Woude CJ. Stromal vascular fraction with platelet-rich plasma injection during surgery is feasible and safe in treatment-refractory perianal fistulising Crohn's disease: A pilot study. Aliment Pharmacol Ther. 2023 Apr;57(7):783-791. doi: 10.1111/apt.17347. Epub 2022 Dec 26."}]}, 'descriptionModule': {'briefSummary': 'Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients presenting with significant symptoms of a rectovaginal fistula (RVF)\n* RVF confirmed on imaging or with a high suspicion based on imaging findings (magnetic resonance imaging \\[MRI\\] and/or endoanal ultrasound \\[EUS\\])\n\nExclusion Criteria:\n\n* Patients with active proctitis\n* Patients with the presence of associated (not properly drained)) pelvic abscess\n* Patients with immune suppressed status\n* Patients with hematological disorders\n* Patients with any oncological event in the five years prior to study'}, 'identificationModule': {'nctId': 'NCT06798935', 'acronym': 'PRS-RVF', 'briefTitle': 'Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas', 'orgStudyIdInfo': {'id': 'MEC-2019-0038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional PRS-injection', 'description': "Patients suffering from rectovaginal fistula's underwent rectovaginal fistula surgery with an additional injection of autologous PRS", 'interventionNames': ['Procedure: autologous platelet-rich stroma']}], 'interventions': [{'name': 'autologous platelet-rich stroma', 'type': 'PROCEDURE', 'description': 'Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma', 'armGroupLabels': ['Additional PRS-injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Capelle aan den IJssel', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Ijsselland Hospital', 'geoPoint': {'lat': 51.92917, 'lon': 4.57778}}], 'overallOfficials': [{'name': 'Oddeke van Ruler, GI- surgeon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IJsselland Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'IJsselland ziekenhuis', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSc', 'investigatorFullName': 'Anne S. Nieuwstraten', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}