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Status unknownNCT04231812Updated Jan 18, 2020

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

An interventional study of Laparoscopic Tissue Morcellation working space (bag) in Laparoscopic Surgical Procedure, sponsored by ARKSurgical. Status unknown. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by ARKSurgical · Not applicable, Interventional, and Device feasibility

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

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.

Read the 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.

02

Conditions studied

  • Laparoscopic Surgical Procedure

Keywords

  • Laparoscopic Tissue Morcellation
03

In context

Lead sponsor

This is the only study on the registry with ARKSurgical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    open lable

    Prospective, open-label

    Device: Laparoscopic Tissue Morcellation working space (bag)

Interventions

  • DeviceLaparoscopic 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

06

What researchers measure

Primary outcomes

  1. Device Related Adverse Events Occurrence

    Occurrence of device use related adverse events as documented and reported, under DSMB review

    Time frame: through study procedure, up to 10 weeks from procedure

  2. 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.

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

Secondary outcomes

  1. Device performance

    Comparison of the presence of cancerous cells pre and post morcellation via peritoneal wash sample cytology

    Time frame: up to 10 weeks following the procedure

  2. Device Performance (usability)

    Ease of use of the device (usability evaluation via questionnaire).

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

  3. Device Performance

    Intra- or post-operative complications, Adverse Events and Device Related Adverse Events

    Time frame: through study procedure, up to 10 weeks from procedure

  4. Device Performance

    Procedure time

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

  5. Device Performance

    Hospitalization length

    Time frame: up to 10 weeks following the procedure

  6. Device Performance

    Specimen (removed tissue) weight collection

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04231812
Lead sponsor
ARKSurgical
Responsible party
Sponsor
First posted
Jan 18, 2020
Start date
Jan 25, 2020 (estimated)
Primary completion
May 1, 2020 (estimated)
Completion
May 1, 2020 (estimated)
Last update
Jan 18, 2020

Study contacts

Stav Tori
Contact
stav@ark-surgical.com
972523594441
Ilana Fishman
Contact
ilana@endpoint.co.il
972547545065
Roy Mashiach, Dr
principal investigator · Assuta Tel Aviv Medical Center, Tel Aviv, Israel
Yuval Kaufman, Dr
principal investigator · Assuta Haifa Medical Center, Haifa, Israel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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