Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT04231812
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2019-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
Sponsor:
ARKSurgical
Organization:
Study Overview
Official Title:
First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: