Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT07289802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair - Multicenter, Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inguinal hernia recurrence rate at 12 months', 'timeFrame': '12 months after index surgery', 'description': 'Proportion of patients with clinically and/or imaging-confirmed inguinal hernia recurrence within 12 months after the index laparoendoscopic repair with 3DMax MID Anatomical Mesh.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain intensity (VAS 0-10)', 'timeFrame': '7-10 days, 30 days, 3 months and 12 months after surgery', 'description': 'Postoperative pain intensity assessed using a 0-10 Visual Analog Scale (VAS) during early and late follow-up. Chronic pain will be defined as VAS ≥4 persisting beyond 3 months after surgery.'}, {'measure': 'Early postoperative complications (≤30 days)', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Incidence of early postoperative complications within 30 days after surgery, including wound infection, hematoma, seroma, urinary retention, bleeding, and other mesh- or procedure-related adverse events.'}, {'measure': 'Late postoperative complications (>30 days to 12 months)', 'timeFrame': 'From >30 days to 12 months after surgery', 'description': 'Incidence of late postoperative complications occurring between 30 days and 6 months after surgery, including chronic groin pain, mesh-related complications, and reoperations in the operated groin.'}, {'measure': 'Groin discomfort and foreign body sensation', 'timeFrame': '7-10 days, 30 days, 3 months and 12 months after surgery', 'description': 'Patient-reported groin discomfort, stiffness and foreign body sensation in the operated region, assessed using standardized questions or Likert-type scales during follow-up contacts.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hernia', 'Mesh', 'Inguinal Hernia', 'Recurrence'], 'conditions': ['Hernia, Inguinal']}, 'referencesModule': {'references': [{'pmid': '39945075', 'type': 'BACKGROUND', 'citation': 'Zamkowski M, S Mietanski M, Franczak P, Gorski D, Grabias J, Janik M, Krol A, Mitura K, Medras O, Nawacki L, Romanczuk M, Rymkiewicz P, Saluk S, Sroczynski P, Sulkowski L, Wieczorek D, Wlodarczyk M. MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial. Ann Surg. 2025 Jun 1;281(6):921-927. doi: 10.1097/SLA.0000000000006669. Epub 2025 Feb 13.'}, {'pmid': '36229552', 'type': 'BACKGROUND', 'citation': 'Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.'}, {'pmid': '37670376', 'type': 'BACKGROUND', 'citation': 'Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.'}, {'type': 'BACKGROUND', 'citation': 'Mateusz Zamkowski, Agnieszka Tomaszewska, Izabela Lubowiecka, Krzysztof Karbowski, Michał Putko, Maciej Śmietański. Mechanical stability of new-generation meshes for M3 inguinal hernia repair: experimental pressure chamber testing of SWING-Mesh® and 3DMax™ MID Anatomical Mesh DOI: 10.20452/wiitm.2025.17990 Published online: October 29, 2025'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice.\n\nThe primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications.\n\nAll participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.', 'detailedDescription': 'Laparoendoscopic techniques such as transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair are widely used for the treatment of inguinal hernia and are associated with faster recovery and lower rates of chronic pain compared with open repair in appropriately selected patients. Mesh reinforcement is a key component of these procedures. Three-dimensional, anatomically contoured meshes have been developed to improve conformability to the myopectineal orifice and to provide stable coverage of the inguinal region, potentially reducing the need for additional fixation and lowering the risk of chronic postoperative pain.\n\nThe 3DMax MID Anatomical Mesh (BD, USA) is a medium-weight, macroporous, pre-shaped polypropylene mesh designed specifically for inguinal hernia repair. Its three-dimensional configuration and recoil properties are intended to facilitate correct positioning and stable coverage of the inguinal anatomy during laparoendoscopic procedures.\n\nThis multicenter, prospective, observational cohort study will include consecutive adult patients undergoing elective TAPP or TEP inguinal hernia repair in participating centers, in whom the operating surgeon has decided to use the 3DMax MID Anatomical Mesh as part of routine practice. No randomization or control group is planned, and no interventions outside standard care will be performed.\n\nData will be collected from medical records and structured follow-up contacts (early postoperative check, approximately 30 days, 3 months and 12 months after surgery). The primary endpoint is hernia recurrence within 12 months. Secondary endpoints include postoperative pain, groin discomfort, foreign body sensation and early or late postoperative complications. Study data will be recorded in a standardized database and analyzed descriptively to characterize the safety profile and clinical performance of the 3DMax MID Anatomical Mesh in real-world practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with primary unilateral or bilateral inguinal hernia undergoing elective laparoendoscopic (TAPP or TEP) repair with implantation of the 3DMax MID Anatomical Mesh in participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Primary unilateral or bilateral inguinal hernia\n* Scheduled for elective laparoendoscopic inguinal hernia repair (TAPP or TEP)\n* Considered suitable for general anesthesia and laparoendoscopic approach by the treating surgeon\n* 3DMax MID Anatomical Mesh planned for use as part of routine clinical care\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age below 18 years\n* Emergency surgery (e.g. incarcerated or strangulated hernia requiring urgent intervention)\n* Contaminated or potentially contaminated surgical field\n* Recurrent inguinal hernia in the same groin (previous repair with mesh or suture)\n* Concomitant procedures or clinical situations in which the surgeon decides that a different mesh concept or technique is required\n* Inability or unwillingness to comply with follow-up schedule (e.g. lack of telephone contact, severe cognitive impairment)'}, 'identificationModule': {'nctId': 'NCT07289802', 'acronym': '3DMS', 'briefTitle': 'Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair - Multicenter, Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Swissmed Hospital'}, 'officialTitle': 'Safety and Efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in Laparoendoscopic Inguinal Hernia Repair: A Multicenter Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '3DMID-PL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3DMax MID TAPP/TEP', 'description': "Adult patients undergoing elective laparoendoscopic inguinal hernia repair (TAPP or TEP) with implantation of the 3DMax MID Anatomical Mesh (BD, USA) as part of routine clinical practice. No randomization or control group is used; all enrolled participants receive the same type of mesh according to the treating surgeon's standard technique.", 'interventionNames': ['Device: 3DMax MID Anatomical Mesh']}], 'interventions': [{'name': '3DMax MID Anatomical Mesh', 'type': 'DEVICE', 'otherNames': ['3DMax MID'], 'description': 'Implantation of a pre-shaped, medium-weight, macroporous polypropylene anatomical mesh (3DMax MID Anatomical Mesh, BD, USA) during elective laparoendoscopic inguinal hernia repair (TAPP or TEP) as part of routine clinical practice. No additional experimental procedures beyond standard surgical care are planned.', 'armGroupLabels': ['3DMax MID TAPP/TEP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mateusz Zamkowski, MD, PhD', 'role': 'CONTACT', 'email': 'zamek@gumed.edu.pl', 'phone': '22 543 33 60'}], 'overallOfficials': [{'name': 'Maciej Śmietański, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'LUX MED Hospital in Gdańsk'}, {'name': 'Mateusz Zamkowski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUX MED Hospital in Gdańsk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swissmed Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}