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

NCT04231812 | Unknown DMC

• 1 other identifier: ARK-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Laparoscopic Surgical Procedure

Keywords

Laparoscopic Tissue Morcellation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Device performance

  up to 10 weeks following the procedure

• Device Performance (usability)

  following completion of procedure and study devise use (1 day)

• Device Performance

  through study procedure, up to 10 weeks from procedure

• Device Performance

  following completion of procedure and study device use (1 day)

• Device Performance

  up to 10 weeks following the procedure

Study Arms (1)

open lable

OTHER

Prospective, open-label

Device: Laparoscopic Tissue Morcellation working space (bag)

Interventions

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

open lable

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Intended use of the device -during the laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• ARKSurgical: lead

Study Officials

• Roy Mashiach, Dr

  Assuta Tel Aviv Medical Center, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

• Yuval Kaufman, Dr

  Assuta Haifa Medical Center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stav Tori

CONTACT

972523594441; stav@ark-surgical.com

Ilana Fishman

CONTACT

972547545065; ilana@endpoint.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: January 18, 2020
• Study Start: January 25, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01