RecruitingNot Applicable

A Prospective Observational Study of Foam Sclerotherapy .

United States100 participantsStarted 2017-11-06

Plain-language 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).

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Pain Inventory

Timeframe: Baseline, 1 month, 6 month, 12 month

Change in Self Assessed Quality of life

Timeframe: Baseline, 1 month, 6 month, 12 month

Change in health related quality of life

Timeframe: Baseline, 1 month, 6 month, 12 month

Change in Polycystic Liver Disease Quality of Life

Timeframe: Baseline, 1 month, 6 month, 12 month

Trial details

NCT IDNCT04111692

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11

Contact for this trial

Cassie Howe, CRC

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

View on ClinicalTrials.gov More Autosomal Dominant Polycystic Kidney trials