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Trial Title:
Feasibility of Cryobiopsy From the Bile Duct - CRYLEO
NCT ID:
NCT06249841
Condition:
Neoplasms, Bile Duct
Conditions: Official terms:
Bile Duct Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
1.1mm flexible Cryoprobe SU
Description:
Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy
(randomized sequence)
Arm group label:
Cryoprobe biopsy against Forceps biopsy
Arm group label:
Forceps biopsy against Cryoprobe biopsy
Other name:
Comparator: SpyBite Max Forceps
Summary:
This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe
SU via percutaneous access in the bile duct. The device has a CE-approval. First
feasibility and safety for application assessed in the bile duct performed ex vivo and in
a patient case report study. The study will take place at 5 different sites in Germany.
Recruitment is competitive. In total, 15 patients will be enrolled. Patients are screened
for study inclusion at the participating hospitals.
Primary objective:
• Feasibility of percutaneous cryobiopsy in the bile duct
Secondary objectives:
- Size of biopsy (mean area (in mm2) of each biopsy technique)
- Percentage of successful retrievals of biopsies by each biopsy technique
- Representativeness of each biopsy sample
- Quality of each biopsy sample
- Grade of crash artifacts occurrence defined as crush artifact area per biopsy
- Rate of safety-relevant aspects, like for example bleeding, post-bleeding,
perforation, infection and abscess
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Suspicion of any neoplastic alterations in the bile duct system or other indication
for biopsy sampling in the bile duct
- A percutaneous drainage or an access by means of percutaneous transhepatic
cholangiodrainage (PTCD) has been previously established independent from study
participation, without adverse events
- Patient is at least 18 years of age
- According to physicians' assessment, patient is able to follow study protocol or is
able to understand the nature, objectives, benefits, implications, risks and
inconveniences of the clinical investigation, able to comply with study requirements
and understand and independently sign the Informed Consent Form
Exclusion Criteria:
- • Presence of hereditary bleeding disorder, e.g. hemophilia A or hemophilia B
- Severe impairment of partial thromboplastin time (PTT) of >80s; International
normalized ratio (INR) >3; platelet count <50,000 /nl
- Dual antiplatelet therapy (change to aspirin monotherapy is no exclusion
criterion)
- Current use of systemic anticoagulation or antiplatelet therapy without the
ability to hold therapy for the recommended amount of time prior to an invasive
procedure (aspirin monotherapy is no exclusion criterion) Patient is
participating in another clinical study pregnant or breast-feeding or intending
to get pregnant during the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christian Gerges, Prof.
Facility:
Name:
Klinikum Hamburg
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Rösch, Prof.
Facility:
Name:
Klinikum Hanau
Address:
City:
Hanau
Zip:
63450
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Axel Eickhoff, Prof.
Facility:
Name:
Klinikum Nürnberg
Address:
City:
Nürnberg
Zip:
90419
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander Dechêne, Prof.
Facility:
Name:
Klinikum Stuttgart
Address:
City:
Stuttgart
Zip:
70174
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jörg G. Albert, Prof.
Start date:
March 4, 2024
Completion date:
March 2025
Lead sponsor:
Agency:
Erbe Elektromedizin GmbH
Agency class:
Industry
Source:
Erbe Elektromedizin GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06249841
