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

NCT04231812 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-01-18

No results posted yet for this study

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

Interventions

DEVICE

Laparoscopic Tissue Morcellation working space (bag)

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

Sponsors & Collaborators

  • ARKSurgical

    lead INDUSTRY

Principal Investigators

  • Roy Mashiach, Dr · Assuta Tel Aviv Medical Center, Tel Aviv, Israel

  • Yuval Kaufman, Dr · Assuta Haifa Medical Center, Haifa, Israel

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-25
Primary Completion
2020-05-01
Completion
2020-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231812 on ClinicalTrials.gov