Status:
ACTIVE_NOT_RECRUITING
Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery
Lead Sponsor:
Microline Surgical, Inc.
Collaborating Sponsors:
AKRN Scientific Consulting, S.L.
Conditions:
Minimally Invasive Surgical Procedures
Laparoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery. This system consists of two med...
Detailed Description
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 inv...
Eligibility Criteria
Inclusion
- Adult subjects, male or female, ≥18 years old
- Subjects who have been scheduled for a laparoscopic surgery using the clip
- Subjects who had provided written informed consent form
- Ability and willingness to comply with all study requirements to be evaluated for each study visit
Exclusion
- Subjects referred for laparoscopic surgeries to reinforce a staple line or produce partial vessel occlusion
- Significant surgical contraindications evaluated using the GOALS score
- Subjects unsuitable for laparoscopic surgery according to PI discretion
- Subjects who have coagulopathy or uninterruptible anticoagulation therapy
- Subjects currently under steroid treatment
- Subject has known allergy to device components (i.e., titanium, stainless steel)
- Subjects who are participating in another trial which may affect the outcomes data on this study
- Inability to adhere to study-related procedures
- Subjects that require emergency surgeries associated with trauma and/or sepsis with a SOFA score ≥ 2 and/or septic shock should be excluded
- Pregnant or lactating women at the time of the surgery
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05363813
Start Date
October 17 2022
End Date
September 1 2025
Last Update
May 8 2025
Active Locations (7)
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1
Centro Hospitalar Universitário Lisboa Norte
Lisbon, Portugal, 1649-028
2
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
4
Complejo Hospitalario Universitario A Coruña del Área Sanitaria de A Coruña y Cee
A Coruña, Spain, 15006