Clinical trial NCT04231812: First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
Official title: First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Surgical Procedure
Keywords: Laparoscopic Tissue Morcellation
Lead sponsor: ARKSurgical
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Pre- menopausal woman patient age 18-50 years
3. Mass measured with diameter up to 10 cm to be removed
4. Normal Pap test result within the last 24 months prior to enrollment
5. Normal and /or Non-Clinically Significant as per investigator discretion CBC and Blood chemistry test within at least 6 months prior to surgery.
6. Signed an informed consent

Exclusion Criteria:

1. Emergency cases
2. Abdominal wall thickness is greater than 10 cm according to US measurements.
3. Patient requires procedure involving the ovaries (e.g., Oophorectomy, Salpingo)
4. Patient is defined as a "high risk" patient for developing cancer (per standard assessment, including but not limited to imaging)
5. Suspicion of malignant or pre-malignant tissue according to preoperative assessment including US exam within 30 days prior to surgery
6. Known or suspected gynecologic malignancy within the past five years
7. Pacemaker, internal defibrillator/cardio converter
8. Previous extensive pelvic surgery or any other medical procedure which in the investigator's judgment contraindicates the patient's participation
9. Contraindications to anesthesia or abdominal surgery. ASA score above 3
10. Concurrent participation in any other clinical study
11. Active infection at the time of the procedure.
12. BMI\<20 or BMI\>40
13. 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.)

Primary outcomes:
measure: Device Related Adverse Events Occurrence
timeFrame: through study procedure, up to 10 weeks from procedure
measure: Device Performance and Integrity
timeFrame: following completion of procedure and study device use (1 day)
Secondary outcomes:
measure: Device performance
timeFrame: up to 10 weeks following the procedure
measure: Device Performance (usability)
timeFrame: following completion of procedure and study devise use (1 day)
measure: Device Performance
timeFrame: through study procedure, up to 10 weeks from procedure
measure: Device Performance
timeFrame: following completion of procedure and study device use (1 day)
measure: Device Performance
timeFrame: up to 10 weeks following the procedure
measure: Device Performance
timeFrame: following completion of procedure and study devise use (1 day)
Other outcomes:
Locations:
Study officials:
affiliation: Assuta Tel Aviv Medical Center, Tel Aviv, Israel
name: Roy Mashiach, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Assuta Haifa Medical Center, Haifa, Israel
name: Yuval Kaufman, Dr
role: PRINCIPAL_INVESTIGATOR
References: