ArticleJSLS : Journal of the Society of Laparoendoscopic Surgeons
Post-Market Clinical Follow-Up Study of the LevaLap 1.0 during Laparoscopic Access.
Article in JSLS : Journal of the Society of Laparoendoscopic Surgeons. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Feasibility of Vibroacoustic Sensing for Detection of Peritoneal Entry During Laparoscopic Access: A Pilot Study in a Human Body Donor.Diagnostics (Basel, Switzerland) · 2026Article
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
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/m 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 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.
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Registered trials
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