Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery

NCT05363813 | Completed DMC FDA Device

• 1 other identifier: PD01-227
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 7

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 medical devices, the M/L-10 Clip Applier and the M/L-10 Clip. The Multi-Fire Clip System is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. This medical device has been marketed in Europe since 2006 and in the United States since 2002, among other places. Laparoscopic surgeries have become the standard of excellence for many surgical procedures as they allow the intervention to be performed in a minimally invasive way, which means significant improvements in factors such as postoperative pain or length of hospital stay compared to open surgeries. Laparoscopic procedures require the use of different hemostatic techniques to minimize blood loss or leakage of other fluids through their respective ducts. Currently, clip and staple placement are the most commonly used procedures for ligation and/or occlusion of blood vessels and other tubular structures. In this context, the Multi-Fire Clip System is presented as an alternative device that can produce significant cost savings due to the reusable design of the M/L-10 Clip Applier. It also provides precise control of bleeding during surgery, which could lead to less potential injury to surrounding structures. The present clinical trial is a PMCF study to evaluate the long-term safety and efficacy of the Multi-Fire Clip System in patients scheduled to undergo laparoscopic surgery in which clip placement is anticipated. During the surgery procedure, the necessary clips will be placed using the aforementioned multi-shot clip system. Participants will be followed up for 6 months after the operation. Through an on-site visit and a telephone call visit, data on possible adverse events related to the device or procedure will be collected in order to assess the long-term safety and efficacy of these devices.

Conditions

Laparoscopy; Leakage of Cardiac Device; Minimally Invasive Surgical Procedures

Keywords

Laparoscopy; PMCF; Laparoscopic surgery; Vessel ligation; Duct ligation; Vessel leakage; Duct leakage

Outcome Measures

Primary Outcomes (1)

• Long-Term Ligation Performance

  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 of laparoscopic surgical procedures.

  6 months after laparoscopic surgical procedures

Secondary Outcomes (6)

• All Serious Adverse Events (SAEs)

  30 days follow-up, and 6 months follow-up after laparoscopic surgical procedures

• Long-term evaluation of Major Adverse Events (MAEs) related to the medical device

  30-days follow-up, and 6-months follow-up

• Long-term evaluation of Major Adverse Events (MAES) related to the procedure

  30-days follow-up, and 6-months follow-up

• Acute Procedural Success (APS)

  One day (during procedure)

• Acute Device Success (ADS)

  One day (during procedure)

Study Arms (1)

Laparoscopic Surgical Patients

EXPERIMENTAL

1. Adult subjects, male or female, ≥18 years old 2. Subjects who have been scheduled for a laparoscopic surgery using the clip 3. Subjects who had provided written informed consent form 4. Ability and willingness to comply with all study requirements to be evaluated for each study visit

Device: M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System)

Interventions

M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System) DEVICE

Permanent ligation of vessels and ducts as part of minimally invasive laparoscopic surgery.

Laparoscopic Surgical Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AKRN Scientific Consulting, S.L.: collaborator
• Microline Surgical, Inc.: lead

Study Sites (7)

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Lisbon District, 1649-028, Portugal

Location

Complejo Hospitalario Universitario A Coruña del Área Sanitaria de A Coruña y Cee

A Coruña, A Coruña, 15006, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Quirónsalud Sagrado Corazón

Seville, Sevilla, 41013, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

Location

Study Officials

• Salvador Morales Conde, MD

  Hospital QuirónSalud Sagrado Corazón, Sevilla, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patient selection based on need for laparoscopic surgical treatment involving vessel or duct ligation.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 6, 2022
• Study Start: October 17, 2022
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); PT (1)