Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04111692

Conditions

Autosomal Dominant Polycystic Kidney

Renal Cyst

Autosomal Dominant Polycystic Liver Disease

Hepatic Cyst

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

An observational prospective study to determine the impact of foam sclerotherapy of large, dominant kidney/liver cysts on quality of life outcomes and kidney/liver cyst volumes at up to 12 months of follow-up in patients with autosomal dominant polycystic kidney disease (ADPKD) and autosomal dominant polycystic liver disease (ADPLD).

Conditions

Autosomal Dominant Polycystic Kidney

Renal Cyst

Autosomal Dominant Polycystic Liver Disease

Hepatic Cyst

Study ID

NCT04111692

Start date

Nov 6, 2017

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Clinical diagnosis of ADPKD or ADPLD
  • 1-3 large, non-exophytic liver or kidney cyst
  • Compressive symptoms from dominant cyst

Exclusion Criteria:

  • Age <18 years
  • Absence of ADPKD or ADPLD
  • Largest cyst <4cm in all 3 dimensions or largest cyst volume <400cc
  • >3 large, non-exophytic liver or kidney cyst(s) ≥4cm in all 3 dimensions (cyst volume ≥400cc)
  • Unwilling to comply with study follow-up protocol to 12 ± 1months post-FS
  • Lacking capacity to provide informed consent to FS of liver or kidney cysts
  • Pregnancy

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Pain Inventory [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Change in Self Assessed Quality of life [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Change in health related quality of life [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Change in Polycystic Liver Disease Quality of Life [ Time Frame: Baseline, 1 month, 6 month, 12 month ]

Central Contacts and Locations

Central contacts

Cassie Howe, CRC

507-266-1230howe.cassie@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Marie C Hogan, MD, PhD

507-266-1963hogan.marie@mayo.edu

Principal Investigator:

Marie C. Hogan, M.D., Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • hepatic cyst
  • Kidney Cyst
  • Autosomal Polycystic Liver Disease
  • Autosomal Polycystic Kidney Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-26.