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Multicenter Study
. 2025 Apr-Jun;29(2):e2025.00014.
doi: 10.4293/JSLS.2025.00014. Epub 2025 May 8.

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

Xavier Deffieux  1 , Jean-Louis Benifla  2 , Ingolf Juhasz-Böss  3 , Moritz Breitbach  3 , Olaf Buchweitz  4 , Nassir Habib  5 , Kirsten Hald  6 , Bashar Haj Hamoud  7 , Cyrille Huchon  2 , Vibeke Lysdal  8 , Meletios P Nigdelis  7 , Martin Rudnicki  8 , Erich-Franz Solomayer  7 , Florin-Andrei Taran  3 , Henrik Michelsen-Wahl  6 , Ricardo Azziz  9   10   11 , Vincenzo Bagnardi  12 , Andreas Hackethal  4
Affiliations
Multicenter Study

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

Xavier Deffieux et al. JSLS. 2025 Apr-Jun.

Abstract

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/m2, 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/m2. 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.

Keywords: Abdominal access; Laparoscopy; Postmarket clinical follow-up; Surgical complications; Veress needle.

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Figures

Figure 1.
Figure 1.
The LevaLap 1.0 device (Core Access Surgical Technologies). The device measures 10 cm in height and 15 cm in diameter. Reproduced with permission from Orsi et al.
Figure 2.
Figure 2.
Utilizing the LevaLap 1.0 device. (A) The LevaLap 1.0 is placed on the abdominal wall at Veress needle insertion site. (B) Standard OR suction is applied to the LevaLap 1.0 port to lift the abdominal wall. (C) Once the abdominal wall has been lifted and is in apposition to the LevaLap 1.0 interior, the Veress needle is inserted, generally at 90° to the abdominal wall, to create the pneumoperitoneum. (D) The Veress needle is retracted, suction is released, and the LevaLap 1.0 removed.
Figure 3.
Figure 3.
Time to achieve satisfactory pneumoperitoneum with the LevaLap 1.0 (n = 158).
See this image and copyright information in PMC

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