Post-Market Clinical Follow-Up Study of the LevaLap 1.0 during Laparoscopic Access

Area of Science:

• Minimally Invasive Surgery
• Surgical Technology
• Gynecologic Surgery

Background:

• The LevaLap 1.0 was developed to enhance the safety, stability, and predictability of abdominal access using the Veress needle.
• This study presents the initial postmarket clinical follow-up (PMCF) data for the LevaLap 1.0 in gynecologic laparoscopic procedures.

Purpose of the Study:

• To evaluate the clinical performance and safety of the LevaLap 1.0 device during gynecologic laparoscopic surgery.
• To assess surgeon experience and procedural outcomes associated with the LevaLap 1.0 system.

Main Methods:

• A prospective, multicenter study was conducted involving 158 women undergoing gynecologic laparoscopy.
• Inclusion criteria focused on adult women without contraindications to Veress needle or laparoscopy, while excluding specific conditions like pregnancy or recent abdominal surgery.

Main Results:

• Successful abdominal access was achieved on the first attempt in 96.8% of cases and within two attempts in 99.4% of cases.
• Surgeons reported increased ease of access (59.5%), confidence (68.3%), control (67.1%), and efficiency (66.4%).
• One minor device-related adverse event (skin redness) was reported, which resolved spontaneously.

Conclusions:

• The LevaLap 1.0 facilitates abdominal access using the Veress needle, offering improved ease, control, and efficiency.
• The device demonstrated a high success rate for initial access, supporting its utility in gynecologic laparoscopy.