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Study to assess the safety, and performance of the LapBox in patients in terms of duration of deployment, organ insertion into the "LapBox" bag, ease of use, success of containment and performance.
The LapBox is intended for use as a laparoscopic instrument port and tissue containment system that creates a working space allowing for visualization during power or manual morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy Ten (10) adult female patients, scheduled for the laparoscopic gynecological procedure, with up to 700gr mass to be removed and with no suspicion of malignancy.
Patients scheduled for elective laparoscopic hysterectomy, myomectomy or removal of an adnexal mass where either manual morcellation or power morcellation is needed for tissue will be enrolled. Each patient will be required to participate in 3 visits:
Visit 1: Screening and Enrollment, as part of the pre-operative visit and confirmation of compliance. Such a visit can be more than 1 day.
Visit 2: Laparoscopic organ removal procedure- morcellation utilizing LapBox containment system.
Visit 3:up appointment up to 7 weeks (7 days) post-procedure.
During visit 2 (laparoscopic organ removal procedure), the following steps will be performed:
Power morcellation:
Following the procedure, tissue weight will be recorded, and leakage testing will be performed on used devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open lable | Other | Prospective, open-label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Tissue Morcellation working space (bag) | Device | The "LapBox" is working space (bag) intended for use as a laparoscopic instrument port and tissue containment system that creates a working space allowing for visualization during power or manual morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy |
| Measure | Description | Time Frame |
|---|---|---|
| Device Related Adverse Events Occurrence | Occurrence of device use related adverse events as documented and reported, under DSMB review | through study procedure, up to 10 weeks from procedure |
| Device Performance and Integrity | Leak testing will be performed following the each procedure to confirm device integrity. Used device will be filled with color fluid to provide clear identification of possible leakage. Test will performed by Investigator delegated study team member and results will be documented in CRF. | following completion of procedure and study device use (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| Device performance | Comparison of the presence of cancerous cells pre and post morcellation via peritoneal wash sample cytology | up to 10 weeks following the procedure |
| Device Performance (usability) |
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Inclusion Criteria:
Exclusion Criteria:
Intended use of the device -during the laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stav Tori | Contact | 972523594441 | stav@ark-surgical.com | |
| Ilana Fishman | Contact | 972547545065 | ilana@endpoint.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Roy Mashiach, Dr | Assuta Tel Aviv Medical Center, Tel Aviv, Israel | Principal Investigator |
| Yuval Kaufman, Dr | Assuta Haifa Medical Center, Haifa, Israel | Principal Investigator |
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|
Ease of use of the device (usability evaluation via questionnaire).
| following completion of procedure and study devise use (1 day) |
| Device Performance | Intra- or post-operative complications, Adverse Events and Device Related Adverse Events | through study procedure, up to 10 weeks from procedure |
| Device Performance | Procedure time | following completion of procedure and study device use (1 day) |
| Device Performance | Hospitalization length | up to 10 weeks following the procedure |
| Device Performance | Specimen (removed tissue) weight collection | following completion of procedure and study devise use (1 day) |