Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05106218
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2021-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the SurroundScope in Urologic Surgical Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients are not aware of the laparoscopic system that will be used during the operation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "For laparoscopic camera system to be used in urological surgeries, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used. This will be compared to the standard laparoscopic system use.\n\nThe study will evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope. The procedure will be performed according to the institution's standard of care, using the SurroundScope or the standard scope for visualization. Each surgery will be captured on video."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'During the surgery - Since the first incision performed till the last incision is closed', 'description': 'Amount of intraoperative adverse event'}, {'measure': 'Length of stay', 'timeFrame': 'Since the surgery completion to discharge from the medical center', 'description': 'Length of stay at the hospital following the surgery in days'}, {'measure': "Surgeon's perception 270surgical", 'timeFrame': 'Immediately following the surgery is completed', 'description': "Surgeon's perception of the 270surgical System - Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree)."}], 'primaryOutcomes': [{'measure': 'Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery', 'timeFrame': 'During the surgery - Since the first incision performed till the last incision is closed', 'description': 'Data collected include - skin to skin time of surgery'}, {'measure': 'Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time', 'timeFrame': 'During the surgery - Since the first incision performed till the last incision is closed', 'description': 'Data collected include - Visibility time of tools and ports in the Field of view'}, {'measure': 'Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals', 'timeFrame': 'During the surgery - Since the first incision performed till the last incision is closed', 'description': 'Data collected include - Time of scope removals during the case to clear smoke or fog'}], 'secondaryOutcomes': [{'measure': 'Time of defined surgical tasks - port placement time', 'timeFrame': 'During the defined surgical task', 'description': 'Time to complete port placement will be measured'}, {'measure': 'Time of defined surgical tasks - transection time', 'timeFrame': 'During the defined surgical task', 'description': 'Time to transection of renal artery \\& Vein with stapler will be measured'}, {'measure': 'Time of defined surgical tasks - clamp time', 'timeFrame': 'During the defined surgical task', 'description': 'Clamp time during partial nephrectomy will be measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Partial Nephrectomy', 'Nephrectomy', 'Laparoscopy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope', 'detailedDescription': 'The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope. 270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will compare the use of the 270Surgical system (The "SurroundScope") to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18\n* Capable of giving informed consent.\n* Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy\n\nExclusion Criteria:\n\n* Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)\n* Patients with contraindications to undergo laparoscopic surgery.\n* Patients with American Society of Anesthesiology (ASA) class\\* \\>3\n* Advanced cirrhosis with failure of hepatic function\n* Patients who have participated in another interventional clinical study in the last month.\n* Pregnancy\n* Unable to consent (due to cultural, language or neurological barriers)'}, 'identificationModule': {'nctId': 'NCT05106218', 'briefTitle': 'Assessment of the SurroundScope in Urologic Surgical Procedures', 'organization': {'class': 'INDUSTRY', 'fullName': '270Surgical'}, 'officialTitle': 'Assessment of the SurroundScope in Urologic Surgical Procedures', 'orgStudyIdInfo': {'id': 'CL 466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SurroundScope', 'description': 'For laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used', 'interventionNames': ['Device: SurroundScope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard laparoscope', 'description': 'For laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used', 'interventionNames': ['Device: Standard Laparoscope']}], 'interventions': [{'name': 'SurroundScope', 'type': 'DEVICE', 'otherNames': ['270System'], 'description': "The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.", 'armGroupLabels': ['SurroundScope']}, {'name': 'Standard Laparoscope', 'type': 'DEVICE', 'description': "The procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization.", 'armGroupLabels': ['Standard laparoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'contacts': [{'name': 'Andrew Nado, MD', 'role': 'CONTACT', 'email': 'nadua@clalit.org.il', 'phone': '+972 (0)547228500'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Andrew Nado, MD', 'role': 'CONTACT', 'email': 'nadua@clalit.org.il', 'phone': '+972 (0)547228500'}], 'overallOfficials': [{'name': 'Andrew Nado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '270Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}