First In Human Study Evaluating the Safety and Performance of the LapBox Containment System for Laparoscopic Tissue Morcellation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: Following tissue harvest and prior to morcellation, a peritoneal wash sample will be obtained for a cytology evaluation. The LapBox will then be inserted to the patient abdomen through the abdominal wall and deployed. The harvested tissue will be inserted into the LapBox using standard technique. The LapBox opening will be extracted outside the abdomen. Depending on the type of morcellation (power or mechanical), the incision may be extended as needed. The appropriate type of port will be placed. Power morcellation: The morcellator will be inserted. The laparoscope will be placed inside the bag and provide visualization of the procedure. Alternatively, direct visualization may be utilized. The morcellator will be operated in a standardized fashion. Manual morcellation will be performed as per standard practice. The LapBox will be removed through the abdominal opening. A second peritoneal wash sample will be obtained for a cytology evaluation in order to compare pre and post morcellation findings. Following the procedure, tissue weight will be recorded, and leakage testing will be performed on used devices.

Official Title
-----------------
First In Human Study Evaluating the Safety and Performance of the LapBox Containment System for Laparoscopic Tissue Morcellation

Conditions
-----------------
Laparoscopic Surgical Procedure

Intervention / Treatment
-----------------
* Device: Laparoscopic Tissue Morcellation working space (bag)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients indicated for elective surgery requiring laparoscopic hysterectomy, myomectomy where either manual morcellation or power morcellation is needed for tissue removal at which a morcellator for cutting and extraction of tissue is required. Pre- menopausal woman patient age 18-50 years Mass measured with diameter up to 10 cm to be removed Normal Pap test result within the last 24 months prior to enrollment Normal and /or Non-Clinically Significant as per investigator discretion CBC and Blood chemistry test within at least 6 months prior to surgery. Signed an informed consent Exclusion Criteria: Emergency cases Abdominal wall thickness is greater than 10 cm according to US measurements. Patient requires procedure involving the ovaries (e.g., Oophorectomy, Salpingo) Patient is defined as a high risk patient for developing cancer (per standard assessment, including but not limited to imaging) Suspicion of malignant or pre-malignant tissue according to preoperative assessment including US exam within 30 days prior to surgery Known or suspected gynecologic malignancy within the past five years Pacemaker, internal defibrillator/cardio converter Previous extensive pelvic surgery or any other medical procedure which in the investigator's judgment contraindicates the patient's participation Contraindications to anesthesia or abdominal surgery. ASA score above 3 Concurrent participation in any other clinical study Active infection at the time of the procedure. BMI<20 or BMI>40 Known history or presence of any medical disorder, which in the investigator's judgment contraindicates the patient's participation (e.g., Known and documented active liver disease, renal failure, cognitive disorder, cardiopulmonary disease, impaired coagulation parameters, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open lable<br>Prospective, open-label | Device: Laparoscopic Tissue Morcellation working space (bag)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic Tissue Morcellation