Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-01 @ 11:54 PM
Study NCT ID:
NCT06813768
Status:
SUSPENDED
Last Update Posted:
2025-02-07
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012006', 'term': 'Rectovaginal Fistula'}, {'id': 'D003424', 'term': 'Crohn Disease'}], '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'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization procedures and statistical analyses will be performed by an investigator not involved in the clinical evaluation or surgical treatment of patients. All clinical evaluations will be performed by independent co-investigators not involved in the surgical procedures and blinded to patient assignment. The dedicated radiologist who will evaluate the MRI scans will be blind to patient allocation. Surgeons will not be able to share information about the treatment used in the surgical procedure and will not be able to participate in any clinical evaluation of the MPC during the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study currently suspended due to device-related issues', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'combined remission', 'timeFrame': '24 weeks', 'description': 'clinical (absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) and radiological (absence of abscesses \\> 3 mm) closure of the fistula'}], 'secondaryOutcomes': [{'measure': 'clinical remission', 'timeFrame': '12, 16, 20, 24 weeks', 'description': 'absence of gas and/or fecal and/or purulent vaginal drainage after gentle digital compression) with radiological presence of abscesses \\> 3 mm'}, {'measure': 'clinical response', 'timeFrame': '12, 16, 20, 24 weeks', 'description': 'at least 50% reduction in drainage of the treated vaginal orifice that was draining at baseline despite gentle digital compression.'}, {'measure': 'failure', 'timeFrame': '12, 16, 20, 24 weeks', 'description': '"no change/worsening" of vaginal drainage and patients who, in the judgment of the investigator, require treatment with antibiotics to control recurrent perianal sepsis'}, {'measure': 'IBDQ score (quality of life)', 'timeFrame': '4, 8, 12, 16, 20, 24 weeks', 'description': 'changes of Inflammatory Bowel Disease Questionnaire (IBDQ) scores'}, {'measure': 'Incidence of adverse events', 'timeFrame': '4, 8, 12, 16, 20, 24 weeks', 'description': 'comparison of incidence of adverse events and serious adverse events in the two arms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MICROFTACTURED ADIPOSE TISSUE', 'BIOLOGIC MESH', 'ENDOANAL FLAP', 'LIPOSUCTION'], 'conditions': ['Rectovaginal Fistula', 'Crohn Disease']}, 'descriptionModule': {'briefSummary': 'Interventional, prospective, randomized, controlled, double blind, parallel groups, nonprofit, single center trial', 'detailedDescription': "The goal of this clinical trial is to compare, the efficacy of\n\n* circumferential infiltration of microfractured autologous adipose tissue combined with the placement of a biological prosthesis in the fistula tract versus\n* endoanal mucosal flap in terms of clinical and radiological healing (combined remission)\n\nin patients with Crohn's rectovaginal fistulas refractory to standard treatment,\n\nSecondary objectives are improvement of the clinical outcome (clinical remission, clinical response, failure), time elapsed between surgery and clinical outcome, onset of any recurrences, safety and improvement in quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients with recto-vaginal fistulas', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed Crohn's disease\n* presence of recto-vaginal fistula refractory to standard treatment (surgical drainage of sepsis and treatment with biological drg for at least 12 months)\n* The patient has received, understood and signed the informed consent to actively participate in the study.\n* The patient is able to understand the conditions of the study and to participate for the whole duration.\n\nExclusion Criteria:\n\n* presence of oostomy\n* Patients with active HIV, hepatitis C (HCV), hepatitis B (HBV), tuberculosis or other uncontrolled septic conditions.\n* Patients who present technical difficulties, in the opinion of the investigator, in safely recovering the amount of adipose tissue necessary for the procedure.\n* Patients with abdominal localization of Crohn's disease who may require general surgery during the study.\n* Patients with active oncological or lymphoproliferative diseases\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT06813768', 'acronym': 'LIPOPLUG', 'briefTitle': "Treatment of Rectovaginal Crohn's Fistula by Combination of TAAM Injection and Biological Plug Placement", 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Trattamento Delle Fistole Rettovaginali Di Crohn Mediante Combinazine Di Plug in Matrice Di Collagene (SURGIMEND®) Ed Infiltrazione Locale Di Tessuto Adiposo Autologo Microfratturato (LIPOGEMS®)', 'orgStudyIdInfo': {'id': 'LIPOPLUG - CROHN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microfractured adipose tissue injection and plug placement', 'description': 'Liposuction (up to 100 cc of adipose tissue) Processing of adipose tissue with lipogems system Drainage of sepsis, courettage of fistula tract Placement of biological prosthesis in the fistula tract, suturing the mesh with interrupted PDS sutures at the internal sphincter Injection of 15 cc of microfractured adipose tissue into the submucosa around the internal orifice and along the fistula tract', 'interventionNames': ['Device: Microfractured adipose tissue injection and plug placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'endoanal mucosa flap', 'description': 'A 6-0 absorbable suture will be placed on the skin at the level of the thigh to simulate liposuction Drainage of sepsis, courettage of fistula tract A U-shaped or vertical endoanal mucous flap will be made, after infiltration with 1:100,000 adrenaline of the mucosa surrounding the internal orifice, mobilization of the mucous flap, closure of the internal orifice at the muscular level with 2-0 absorbable stitches of PDS and suture of the mucosal flap with 3-0 absorbable vycril sutures.', 'interventionNames': ['Device: Microfractured adipose tissue injection and plug placement']}], 'interventions': [{'name': 'Microfractured adipose tissue injection and plug placement', 'type': 'DEVICE', 'otherNames': ['Lipogems LGD 60 CND V0599 - RDM 1256088', 'Surgimend AWR 3X3 cm, 606-001-012 DM 409689/R'], 'description': 'surgery + infiltration of micro-fractured autologous adipose tissue at the level of the internal orifice and placement of a biological prosthesis', 'armGroupLabels': ['Microfractured adipose tissue injection and plug placement', 'endoanal mucosa flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Silvio Laureti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}