SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-14

Study Completion Date

2024-05-02

Brief Summary

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To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate.

Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations

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Detailed Description

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Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.

Conditions

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BPH Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Solep Arm

Use of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure

SOLTIVE Thulium Laser

Intervention Type OTHER

Use of SOLTIVE Thulium laser for HoLEP

Control Arm

Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure

Standard of Care (Holmium Laser)

Intervention Type OTHER

Use of Holmium laser for HoLEP

Interventions

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SOLTIVE Thulium Laser

Use of SOLTIVE Thulium laser for HoLEP

Intervention Type OTHER

Standard of Care (Holmium Laser)

Use of Holmium laser for HoLEP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients must be 18 years of age or older
2. Patients must be diagnosed with benign prostatic hyperplasia
3. Patients must opt for surgical management of their BPH with laser enucleation

Exclusion Criteria

1. Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
2. Patients with prostate glands greater or equal to 200 grams
3. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No