The RELAP PMCF will be conducted as a prospective, single-arm, open-label and
multi-center clinical investigation and will include up to 230 subjects derived for
laparoscopic surgery. The clinical investigation will be conducted in up to 12 sites
located in European countries. Additional sites or other countries may be approached for
participation in the clinical investigation if needed.
The primary objective of the RELAP Post-Market Clinical Follow-Up Study is to determine
the long-term effectiveness of the Multi-Fire Clip System through 6-months follow-up. The
secondary objective of the RELAP Post-Market Clinical Follow-Up Study is focused on the
long-term evaluation of Multi-Fire Clip System safety and effectiveness through the
collection of Serious Adverse Events (SAEs) and Major Adverse Events (MAEs) related to
both the medical device and the procedure.
The primary safety and efficacy endpoint is the efficacy of long-term vessel/duct
ligation defined as absence of Adverse Events (AEs) related to vessel and/or duct leakage
due to incomplete ligation of the vessel/duct after appropriate placement of clip at 6
months in patients indicated for laparoscopic surgical procedure.
There are several secondary endpoints planned for his clinical investigation. Firstly,
all serious adverse events (SAEs) will be evaluated at 6 months. Additionally, a
long-term evaluation of major adverse events (MAEs) related to both the medical device
and the procedure. A Risk Ratio (RR) will be defined for the analysis of this secondary
endpoint. The time frame for the long-term evaluation will be 30-days follow-up and
6-months follow-up. Moreover, the Acute Procedural Success (APS), defined as the absence
of (S)AEs within 24h after the surgery, will be assessed. The Acute Device Success,
defined as the absence of (S)AEs related to the devices within the 24h after the surgery
will also be evaluated. Finally, the Length of Stay (LoS) in the hospital will be
evaluated.
The Clinical Investigation visits will occur at Baseline, Procedure and 30-days
follow-up, with a final phone call at 6 months will take place. This clinical
investigation will enroll male and female adult subjects who have been scheduled for a
laparoscopic surgery using a clip. Subjects must meet all eligibility criteria and
provide written informed consent prior to conducting any investigation-specific
procedures not considered standard of care. The target population are subjects that
require a laparoscopic surgery and a clip can be used to occlude a vessel/duct.
Approximately 230 subjects will be enrolled in the clinical investigation in order to
assess the primary endpoint. The expected duration of enrollment is up to 12 months. The
expected duration of each subject's participation is 6 months, including the scheduled
visits and data collection for this clinical investigation that will occur during the
"early follow-up visit" at 30 days after the procedure and 6 months. The subject
follow-up will be considered completed at the conclusion of their 6-month follow-up
visit. Therefore, the total duration of the clinical investigation is expected to be 18
months.
Regarding the statistical analysis, the primary safety and effectiveness endpoint results
will be compared with the data reported in the literature for similar medical devices.
The analysis population will be the per-protocol (PP) population, and the results will be
presented as the incidence (in percentage) of AEs related to leakage, with a 95%
confidence. Further analyses using the PP population will be performed in order to verify
the statistical robustness of the results. Secondary endpoints of this clinical
investigation will refer to the assessment of the safety of laparoscopic surgical
procedures through the collections of all SAEs reported at 6 months. In all cases, the PP
population will be the analysis population, and results will be presented as a
percentage, defining a Risk Ratio (RR), with 95% confidence. Other secondary endpoints of
this clinical investigation include the acute device success and acute procedural
success, which will be assessed during procedure. Besides, the length of hospital stay
will also be analyzed, and data will be presented as total number of days.
The sample size calculation is based on the purpose to demonstrate non-inferiority of
Multi-Fire Clip System compared to other metallic clips in terms of AEs related to fluid
leakage. This assessment will allow to define a success rate of the long-term
effectiveness and safety of M/L-10 Multi-Fire Clip System.
Primary data collection based on source-documented hospital and/or clinic chart reviews
will be performed clearly and accurately by site personnel trained on the Clinical
Investigation Plan (CIP) and Case Report Form (CRF) completion. The investigator will
ensure accuracy, completeness, legibility and timeliness of the data reported to the
Sponsor on the CRFs and in all required reports. Data on CRFs will be collected for all
subjects that are enrolled into the clinical investigation. A Data Management Plan (DMP)
will describe procedures used for data entry and collection. Data review and data
cleaning, and issuing, resolving data discrepancies and methods for data base lock. The
DMP will include procedures for the verification, validation and securing of electronic
clinical system. The investigator/site will permit direct access to source data/documents
for the purpose of performing clinical investigation-related monitoring, audits, EC
review and regulatory inspections. Regulations and GCP require the Investigator to
maintain information in the subject's original medical records that corroborates data
collected on the CRFs. In order to comply with these regulatory requirements/GCP, medical
history data, adverse events reported and their resolution as well as any other data
required to substantiate data entered into the CRF, will be recorded. Data on CRFs will
be collected for all subjects that are enrolled into the clinical investigation.
Sponsor and/or designee will monitor the clinical investigation over its duration
according to the CIP-specific monitoring plan which will include the planned extent of
source data verification. This monitoring plan will be a separate document that can be
updated during the course of the study. As for the safety monitoring, Measures taken to
avoid bias related to safety includes 100% of source data verification related to AEs
documented in the Monitoring Plan. A Sponsor representative or designee may request
access to all clinical investigation records, including source documentation, for
inspection during a Quality Assurance audit.
This clinical investigation, sponsored by Microline Surgical Inc. (Beverly, USA), will be
conducted in accordance with this CIP. All investigators involved in the conduct of the
clinical investigation will be qualified by education, training, or experience to perform
their tasks and this training will be documented appropriately.