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

BACKGROUND AND OBJECTIVES

The LevaLap 1.0 (Core Access Surgical Technologies, Atlanta, GA) was designed to promote safer, more stable, and more predictable abdominal access when using the Veress needle for insufflation. We report on the first postmarket clinical study (PMCF) assessing experience with the use of the LevaLap 1.0 during gynecologic laparoscopic surgery.

METHODS

Prospective multicenter study, including women ≥18 years old, excluding pregnancy, access site surgery in prior 10 days, abdominal hernia, contraindication to Veress needle or laparoscopy use, body mass index (BMI) >30 kg/m, and inability/unwillingness to provide consent.

RESULTS

A total of 158 subjects were included, involving nine surgeons. Mean age was 43.6 ± 14.6 years and mean BMI: 24.7 ± 3.8 kg/m. Access site was 83.5% transumbilical, 15.2% periumbilical, and 1.2% other. Using the device 96.8% (95% confidence interval [CI]: 92.8-99.0%, n = 152/157) of patients' access was successfully achieved at first attempt and 99.4% (95% CI: 96.5-100.0, n = 156/157) within the first 2 attempts. One minor device-related adverse event was reported: a circular redness on the skin at the site of device application, resolving spontaneously. Surgeons noted easier access in 59.5%, increased confidence in 68.3%, increased access control in 67.1%, and increased access efficiency in 66.4% of cases.

CONCLUSION

This PMCF study indicates that the use of the LevaLap 1.0 resulted in easier, greater control and greater efficiency during abdominal access using the Veress needle. In 96.8% access was achieved at first attempt and in 99.4% within the first 2 attempts. The use of the LevaLap 1.0 may facilitate abdominal access when using the Veress needle for insufflation.