Gallbladder NeoplasmsIRENCT02430662
Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms
A study testing Irreversible electroporation (IRE) and NanoKnife in people with Gallbladder Neoplasms, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gallbladder Neoplasms
- What is being tested?
- Irreversible electroporation (IRE) and NanoKnife
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Mar 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gallbladder Neoplasms diagnosed by positive biopsy or non-invasive criteria,
- Not suitable for surgical resection,
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- A prothrombin time ratio > 50%,
- Platelet count > 80x10^9/L,
- Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
- Able to comprehend and willing to sign the written informed consent form (ICF),
- Have a life expectancy of at least 3 months.
Who cannot join
- Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
- Any active implanted device (eg Pacemaker),
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
- Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Trial locations and contacts
1 site in 1 country.
China1 site
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms: Phase I and Phase II Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.
Read the detailed description
By enrolling patients with unresectable Gallbladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Gallbladder Neoplasms.
- Conditions
- Gallbladder Neoplasms
- Being tested
- Irreversible electroporation (IRE), NanoKnife
- Keywords
- irreversible electroporation, Unresectable Gallbladder Neoplasms
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporation (IRE)Procedure or surgery
Also called NanoKnife
Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
NanoKnifeDevice
| Study group | Role | What they receive |
|---|---|---|
| IRE Group | Experimental | irreversible electroporation for Unresectable Gallbladder Neoplasms Receives: Procedure: Irreversible electroporation (IRE); Device: NanoKnife |
| Control | No intervention | The patients without treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Measured: 6 month
Secondary outcomes (4)
Percentage of lesions that show no sign of recurrence 12 months after IRE
Measured: 12 months
A minimum and maximum range of voltage for safe and effective IRE
Measured: 3 months
Progress free disease (PFS)
Measured: 12 months
Overall survival (OS)
Patients will be followed for 36 months after IRE for OS analyzed.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study start1 Jan 2015
- Primary completion1 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder NeoplasmsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, PhD, Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430662
- Sponsor's protocol ID
- Gallbladder Neoplasms-IRE-01
- Acronym
- IRE
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation(IRE) For Unresectable Gallbladder Neoplasms: Phase I and Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02430662
- Acronym / sponsor ID
- IRE / Gallbladder Neoplasms-IRE-01
- Conditions
- Gallbladder Neoplasms
- Keywords
- irreversible electroporation, Unresectable Gallbladder Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 30 Apr 2015 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Gallbladder Neoplasms.
Detailed description
By enrolling patients with unresectable Gallbladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Gallbladder Neoplasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE Group | Experimental | Procedure: Irreversible electroporation (IRE), Device: NanoKnifeirreversible electroporation for Unresectable Gallbladder Neoplasms |
| Control | No intervention | –The patients without treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Gallbladder Neoplasms diagnosed by positive biopsy or non-invasive criteria,
- Not suitable for surgical resection,
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- A prothrombin time ratio > 50%,
- Platelet count > 80x10^9/L,
Key exclusion criteria (5 listed)
- Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
- Any active implanted device (eg Pacemaker),
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
- Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
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 |
|---|---|---|
| Irreversible electroporation (IRE)Also: NanoKnifeIrreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT. | Procedure or surgery | IRE Group |
| NanoKnife | Device | IRE Group |
Primary outcome
Number of participants with Adverse events
Time frame: 6 month
4 secondary outcomes
Percentage of lesions that show no sign of recurrence 12 months after IRE
Time frame: 12 months
A minimum and maximum range of voltage for safe and effective IRE
Time frame: 3 months
Progress free disease (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 36 months
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 5 Sep 2021.
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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.
Lizhi Niu, PhD study chair
Fuda Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible electroporation (IRE) and NanoKnife in people with Gallbladder Neoplasms, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
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 8 inclusion and 5 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Number of participants with Adverse events (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.