Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 11:59 AM
Study NCT ID:
NCT05243433
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedure-specific complications', 'timeFrame': 'During procedure'}, {'measure': 'Procedure duration', 'timeFrame': 'During procedure'}, {'measure': 'Recovery time', 'timeFrame': '30 days'}, {'measure': 'Post-operative pain (Visual analogue scale 0 - no pain to 10 - worst pain possible)', 'timeFrame': '1 day after procedure'}, {'measure': 'Number of rehospitalization per patient within 30 days', 'timeFrame': '30 days'}, {'measure': 'Number of repeat surgery or reintervention per patient within 30 days', 'timeFrame': '30 days'}, {'measure': 'Surgeon comfort evaluated on 1-10 scale at the end of the procedure (1-not comfortable, 10-very comfortable)', 'timeFrame': 'During procedure'}, {'measure': 'Surgeon satisfaction with the level of assistance provided by the Maestro platform, on 1-10 scale at the end of the procedure (1-assistance much worse than a human assistant, 5-equivalent to human assistant, 10-much better than human assistant)', 'timeFrame': 'During procedure'}, {'measure': 'Study device usability on 1-10 scale at the end of the procedure (1-very hard to use, 5-not difficult but not easy, 10-very easy to use)', 'timeFrame': 'During procedure'}], 'primaryOutcomes': [{'measure': 'Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications', 'timeFrame': '30 days'}, {'measure': 'Completion of the procedure using the Maestro Platform without conversion to a manual minimally invasive or open surgical procedure specifically due to a device failure or malfunction', 'timeFrame': 'During procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominal laparoscopic surgery', 'laparoscopic cholecystectomy', 'laparoscopic hernia repair', 'laparoscopic appendectomy', 'laparoscopic bariatric surgery', 'laparoscopic colectomy'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: ≥ 18 to ≤ 75 years\n* Scheduled for one of the following non-emergent laparoscopic procedure: cholecystectomy, hernia repair, appendectomy, bariatric surgery (gastric sleeve or gastric bypass), or colectomy.\n* Willing to comply with protocol-specified follow-up evaluation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Advanced refusal of blood transfusion, if necessary;\n* Active systemic or cutaneous infection or inflammation;\n* Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;\n* Uncontrolled diabetes mellitus;\n* Known, significant history of bleeding diathesis, or coagulopathy, or Von Willebrand's disease or current platelet count \\< 100,000 cells/mm3, or baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);\n* Severe co-existing morbidities having a life expectancy of less than 30 days;\n* Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study;\n* Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;\n* Renal insufficiency (serum creatinine of \\> 2.5 mg/dl);\n* Females who are pregnant, planning to become pregnant within three months of the procedure, or lactating;\n* Extreme morbid obesity (BMI greater than 45 kg/m2);\n* Patients presenting with ascites;\n* Patients presenting for emergency surgery;\n* Previous surgery in the same anatomical location;\n* Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)"}, 'identificationModule': {'nctId': 'NCT05243433', 'acronym': 'Maestro', 'briefTitle': 'Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Moon Surgical'}, 'officialTitle': 'Maestro LIFT-OFF: A Feasibility, Prospective, Single Center, Single-arm Study of the Maestro Surgical Assistance Device in Abdominal Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'Maestro LIFT-OFF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procedure using the Maestro Platform', 'description': 'Study participants will be adults aged ≥ 18 to ≤ 75 years scheduled for a non-emergent laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy.', 'interventionNames': ['Device: Laparoscopic surgery using the Maestro Platform']}], 'interventions': [{'name': 'Laparoscopic surgery using the Maestro Platform', 'type': 'DEVICE', 'description': 'Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.', 'armGroupLabels': ['Procedure using the Maestro Platform']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU St Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Guy-Bernard CADIERE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Saint-Pierre, Brussels, Belgique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moon Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}