Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

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NeuroTherapia, Inc.

Status

Enrolling

Conditions

Kidney Stone

Treatments

Device: vacuum assisted sheath
Device: passive suction via conventional sheath

Study type

Interventional

Funder types

Other

Identifiers

NCT05993546
23-104

Details and patient eligibility

About

The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Full description

In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own. Two procedure types will be investigated: Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone. Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with planned prone mini-PCNL and a preoperative NCCT
  • Primary stone size: 10-25 mm
  • Pre-existing indwelling nephrostomy tube or ureteral stent permitted
  • Age: ≥ 18 years old
  • Gender: all
  • Ethnicity: all
  • Capable of giving informed consent
  • Capable and willing to fulfill requirements of the study

Exclusion criteria

  • Anticoagulated or history of coagulopathy
  • Congenital renal anomalies
  • Prior ipsilateral upper urinary tract reconstructive procedures
  • Conversion to open procedure
  • Multiple access tracts
  • Inability to give informed consent or unable to meet requirements of the study for any reason

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

90 participants in 2 patient groups

vacuum-assisted sheath
Active Comparator group
Treatment:
Device: vacuum assisted sheath
passive suction via conventional sheath
Active Comparator group
Treatment:
Device: passive suction via conventional sheath

Trial contacts and locations

0

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Central trial contact

Marina Markovic

Data sourced from clinicaltrials.gov

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