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. 2023 Apr;30(4):1366-1375.
doi: 10.1007/s43032-022-01033-7. Epub 2022 Aug 8.

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids

Michael G Tal  1 , Ran Keidar  2   3 , Gilad Magnazi  4 , Ohad Henn  4 , Jin Hee Kim  5 , Scott G Chudnoff  6 , Kevin J Stepp  7
Affiliations

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids

Michael G Tal et al. Reprod Sci. 2023 Apr.

Abstract

The purpose of this study was to assess the feasibility of use of a novel uterine fibroid treatment device hypothesized to cause fibroid infarction by increasing intra-tumoral pressure. Between August 2019 and January 2020, 21 uterine fibroids were treated in 16 symptomatic pre-menopausal black women. Pelvic magnetic resonance imaging was performed before the procedure, a day after the procedure and at 1, 3, 6, and 12 months. The subjects were also followed for clinical outcomes and quality of life up to 12 months at a single investigational site. At 3 months, the mean reduction in the fibroid volume was 36.3% (P = .002). Incremental reduction in volume peaked at the end of the follow-up, at the 12-month mark (60.4%; P = .008). There were no procedures in which the users failed to perform laparoscopic pressure suturing of fibroids with the pressure-induced fibroid ischemia device. Improvement in the quality of life was evident in the Health-Related Quality of Life total, Energy/Mood, Control, and Sexual Function domains of the Uterine Fibroid Symptom and Quality of Life questionnaire at 3 months post-procedure. Unanticipated risks were not identified. Serious adverse events were not identified. The initial clinical assessment of the pressure-induced fibroid ischemia device supports feasibility of the approach and does not reveal serious safety concerns. Trial is currently being registered retrospectively (This was a feasibility study and therefore registration was not mandatory).

Keywords: Fibroid; Ischemia; Pressure; Suturing.

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Conflict of interest statement

MG Tal, R Keidar, G Magnazi, O Henn, and KJ Stepp declared having equity in Empress Medical, which developed and manufactured the Empress Fibroid Treatment System.

Figures

Fig. 1
Fig. 1
Illustration of a the PIFI system and b the mechanism of the treatment action
Fig. 2
Fig. 2
Consolidated Standards of Reporting Trials (CONSORT) flow diagram
Fig. 3
Fig. 3
MRI—gadolinium-enhanced fat-suppressed T1-weighted images of a uterine fibroid a before the treatment—arrows point to the treated fibroid; b 12 months after the treatment; c 1 day after the treatment—arrows mark the sites at which sutures were placed with the PIFI system
See this image and copyright information in PMC

References

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