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Prospective pilot study: Comparison of the efficacy and safety of two different paracentesis systems in the context of therapeutic ascites paracentesis

Prospective pilot study: Comparison of the efficacy and safety of two different paracentesis systems in the context of therapeutic ascites paracentesis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036982
Enrollment
40
Registered
2025-05-23
Start date
2025-06-09
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R18

Interventions

Group 1: Single therapeutic paracentesis in patients with symptomatic ascites (indication for paracentesis is independent of this study) using the 6F paracentesis needle ‘PerkuFlow according to Schlot

Sponsors

Universitätsmedizin Göttingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Large volume ascites -Indication for therapeutic ascites puncture independent of this study -Voluntary participation, ability to give informed consent

Exclusion criteria

Exclusion criteria: -Patients younger than 18 years -Patient unable to give consent -Lack of consent

Design outcomes

Primary

MeasureTime frame
1. amount of drained ascites (ml) 2. amount of residual ascites after paracentesis (as a surrogate: distance from peritoneum to bowel loop at puncture site in supine position in mm)

Secondary

MeasureTime frame
1. duration of paracentesis (minutes) 2. duration until the first 1000ml of ascites is drained (seconds) 3. pain (NRS 0-10) during puncture/paracentesis (puncture and during drainage) 4. complications a. Bleeding (minor/major) within 24 hours b. Leakage from puncture channel after >24h c. Pain (NRS 0-10) after >24h d. Injury to neighbouring organs/peritonitis within 24h

Countries

Germany

Contacts

Public ContactGolo Petzold

Universitätsmedizin Göttingen

golo.petzold@med.uni-goettingen.de+49 5513962313

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026