Laparoscopic Surgical ProcedureNCT04231812
First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
A study testing Laparoscopic Tissue Morcellation working space (bag) in people with Laparoscopic Surgical Procedure, run by ARKSurgical.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Laparoscopic Surgical Procedure
- What is being tested?
- Laparoscopic Tissue Morcellation working space (bag)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2020to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.)
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Laparoscopic Surgical Procedure
- Being tested
- Laparoscopic Tissue Morcellation working space (bag)
- Keywords
- Laparoscopic Tissue Morcellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| open lable | Other | Prospective, open-label Receives: Device: Laparoscopic Tissue Morcellation working space (bag) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Related Adverse Events Occurrence
Occurrence of device use related adverse events as documented and reported, under DSMB review
Measured: 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.
Measured: following completion of procedure and study device use (1 day)
Secondary outcomes (6)
Device performance
Comparison of the presence of cancerous cells pre and post morcellation via peritoneal wash sample cytology
Measured: up to 10 weeks following the procedure
Device Performance (usability)
Ease of use of the device (usability evaluation via questionnaire).
Measured: following completion of procedure and study devise use (1 day)
Device Performance
Intra- or post-operative complications, Adverse Events and Device Related Adverse Events
Measured: through study procedure, up to 10 weeks from procedure
Device Performance
Procedure time
Measured: following completion of procedure and study device use (1 day)
Device Performance
Hospitalization length
Measured: up to 10 weeks following the procedure
Device Performance
Specimen (removed tissue) weight collection
Measured: following completion of procedure and study devise use (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 Jan 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARKSurgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy Mashiach, Dr, Principal investigator, Assuta Tel Aviv Medical Center, Tel Aviv, IsraelYuval Kaufman, Dr, Principal investigator, Assuta Haifa Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231812
- Sponsor's protocol ID
- ARK-001
- Status last verified
- Jan 2020
- First submitted
- 24 Dec 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
- ClinicalTrials.gov ID
- NCT04231812
- Acronym / sponsor ID
- ARK-001
- Conditions
- Laparoscopic Surgical Procedure
- Keywords
- Laparoscopic Tissue Morcellation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ARKSurgicalIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open lable | Other | Device: Laparoscopic Tissue Morcellation working space (bag)Prospective, open-label |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | open lable |
Primary outcome
Device Related Adverse Events Occurrence
Time frame: through study procedure, up to 10 weeks from procedure
Occurrence of device use related adverse events as documented and reported, under DSMB review
Device Performance and Integrity
Time frame: following completion of procedure and study device use (1 day)
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.
6 secondary outcomes
Device performance
Time frame: up to 10 weeks following the procedure
Device Performance (usability)
Time frame: following completion of procedure and study devise use (1 day)
Device Performance
Time frame: through study procedure, up to 10 weeks from procedure
Device Performance
Time frame: following completion of procedure and study device use (1 day)
Device Performance
Time frame: up to 10 weeks following the procedure
Device Performance
Time frame: following completion of procedure and study devise use (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Mashiach, Dr principal investigator
Assuta Tel Aviv Medical Center, Tel Aviv, Israel
Yuval Kaufman, Dr principal investigator
Assuta Haifa Medical Center, Haifa, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Tissue Morcellation working space (bag) in people with Laparoscopic Surgical Procedure, run by ARKSurgical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stav Tori (972523594441, stav@ark-surgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Related Adverse Events Occurrence (time frame: through study procedure, up to 10 weeks from procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.