Neoplasms, Bile DuctCRYLEONCT06249841
Feasibility of Cryobiopsy from the Bile Duct - CRYLEO
A study testing 1.1mm flexible Cryoprobe SU in people with Neoplasms, Bile Duct, run by Erbe Elektromedizin GmbH at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Bile Duct
- What is being tested?
- 1.1mm flexible Cryoprobe SU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesGermany
- Study dates
- 4 Mar 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinikum Essen
Essen, Hesse, 45147
Klinikum Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20246
Klinikum Hanau
Hanau, Hanau, 63450
Klinikum Nürnberg
Nuremberg, Nürnberg, 90419
Klinikum Stuttgart
Stuttgart, Stuttgart, 70174
About this study
Official title: Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO
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:
Read more
- 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
- Conditions
- Neoplasms, Bile Duct
- Being tested
- 1.1mm flexible Cryoprobe SU
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.1mm flexible Cryoprobe SUDevice
Also called Comparator: SpyBite Max Forceps
Six tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence)
| Study group | Role | What they receive |
|---|---|---|
| Forceps biopsy against Cryoprobe biopsy | Experimental | A total of 6 forceps biopsies and 3 cryobiopsies will be taken for each patient, corresponding to a 2:1 ratio. The biopsies are divided into blocks of two (6 forceps, 3 cryo). The biopsy technique blocks are randomized, resulting in a sequence of 6 forceps biopsies followed by 3 cryobiopsies Receives: Device: 1.1mm flexible Cryoprobe SU |
| Cryoprobe biopsy against Forceps biopsy | Active comparator | A total of 6 forceps biopsies and 3 cryobiopsies will be taken for each patient, corresponding to a 2:1 ratio. The biopsies are divided into blocks of two (6 forceps, 3 cryo). The biopsy technique blocks are randomized, resulting in a sequence of 3 cryobiopsies followed by 6 forceps biopsies. Receives: Device: 1.1mm flexible Cryoprobe SU |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient.
Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient
Measured: 30 days
Secondary outcomes (6)
Size of biopsy (mean area (in mm2) of each biopsy technique)
Quality of biopsies
Measured: 30 days
Percentage of successful retrievals of biopsies by each biopsy technique
Quality of biopsies
Measured: 30 days
Representativeness of each biopsy sample
yes: evaluable bile duct epithelia in sufficient quantity and quality to make a diagnosis or no: absent or not sufficiently evaluable bile duct epithelia (e.g. crush artefacts, dissolved tissue association
Measured: 30 days
Quality of each biopsy sample
Biopsy quality using a Likert-Scale for each biopsy technique
Measured: 30 days
Grade of crash artifacts occurrence defined as crush artifact area per biopsy
Quality of biopsies
Measured: 30 days
Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
Quality of biopsies
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start4 Mar 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, Bile DuctStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erbe Elektromedizin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249841
- Sponsor's protocol ID
- CIV-23-06-043299
- Acronym
- CRYLEO
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peveling-Oberhag J, Zimmermann C, Linzenbold W, Ott G, Enderle M, Albert JG. Bile duct tissue acquisition by cholangioscopy-guided cryobiopsy technique: first-in-human application. VideoGIE. 2023 Feb 15;8(4):158-161. doi: 10.1016/j.vgie.2022.12.007. eCollection 2023 Apr.
PubMed 37095838Walter D, Peveling-Oberhag J, Schulze F, Bon D, Zeuzem S, Friedrich-Rust M, Albert JG. Intraductal biopsies in indeterminate biliary stricture: Evaluation of histopathological criteria in fluoroscopy- vs. cholangioscopy guided technique. Dig Liver Dis. 2016 Jul;48(7):765-70. doi: 10.1016/j.dld.2016.03.013. Epub 2016 Mar 26.
PubMed 27067926
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of in Vivo Percutaneous Cryobiopsy from the Human Bile Duct - CRYLEO
- ClinicalTrials.gov ID
- NCT06249841
- Acronym / sponsor ID
- CRYLEO / CIV-23-06-043299
- Conditions
- Neoplasms, Bile Duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Erbe Elektromedizin GmbHIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forceps biopsy against Cryoprobe biopsy | Experimental | Device: 1.1mm flexible Cryoprobe SUA total of 6 forceps biopsies and 3 cryobiopsies will be taken for each patient, corresponding to a 2:1 ratio. The biopsies are divided into blocks of two (6 forceps, 3 cryo). The biopsy technique blocks are randomized, resulting in a sequence of 6 forceps biopsies followed by 3 cryobiopsies |
| Cryoprobe biopsy against Forceps biopsy | Active comparator | Device: 1.1mm flexible Cryoprobe SUA total of 6 forceps biopsies and 3 cryobiopsies will be taken for each patient, corresponding to a 2:1 ratio. The biopsies are divided into blocks of two (6 forceps, 3 cryo). The biopsy technique blocks are randomized, resulting in a sequence of 3 cryobiopsies followed by 6 forceps biopsies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- • Presence of hereditary bleeding disorder, e.g. hemophilia A or hemophilia B
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.1mm flexible Cryoprobe SUAlso: Comparator: SpyBite Max ForcepsSix tissue samples retrieved by standard biopsy forceps and three samples by cryobiopsy (randomized sequence) | Device | Cryoprobe biopsy against Forceps biopsy, Forceps biopsy against Cryoprobe biopsy |
Primary outcome
The primary endpoint of this study is feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient.
Time frame: 30 days
Feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient
6 secondary outcomes
Size of biopsy (mean area (in mm2) of each biopsy technique)
Time frame: 30 days
Percentage of successful retrievals of biopsies by each biopsy technique
Time frame: 30 days
Representativeness of each biopsy sample
Time frame: 30 days
Quality of each biopsy sample
Time frame: 30 days
Grade of crash artifacts occurrence defined as crush artifact area per biopsy
Time frame: 30 days
Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 37095838Peveling-Oberhag J, Zimmermann C, Linzenbold W, Ott G, Enderle M, Albert JG. Bile duct tissue acquisition by cholangioscopy-guided cryobiopsy technique: first-in-human application. VideoGIE. 2023 Feb 15;8(4):158-161. doi: 10.1016/j.vgie.2022.12.007. eCollection 2023 Apr.
- Background: PubMed 27067926Walter D, Peveling-Oberhag J, Schulze F, Bon D, Zeuzem S, Friedrich-Rust M, Albert JG. Intraductal biopsies in indeterminate biliary stricture: Evaluation of histopathological criteria in fluoroscopy- vs. cholangioscopy guided technique. Dig Liver Dis. 2016 Jul;48(7):765-70. doi: 10.1016/j.dld.2016.03.013. Epub 2016 Mar 26.
Related trials for Neoplasms, Bile Duct
RecruitingPhase 1/2
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Biliary Cancer, Bile Duct Cancer
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1/2
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
Solid Tumor, NSCLC
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.1mm flexible Cryoprobe SU in people with Neoplasms, Bile Duct, run by Erbe Elektromedizin GmbH at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is feasibility of percutaneous cryobiopsy in the bile duct, i.e., successful retrieval of at least one cryobiopsy specimen per patient. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.