NCT02335827

Brief Summary

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

June 1, 2020

Enrollment Period

5.4 years

First QC Date

January 2, 2015

Last Update Submit

September 1, 2021

Conditions

Renal Tumor

Keywords

irreversible electroporationrenal tumor

Outcome Measures

Primary Outcomes (3)

  • adverse effects

    adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.

    1 month

  • Quality of Life (QoL)

    Quality of Life assessed as WHOQOL-BREF.

    2 months

  • procedural compliance

    compliance will be analyzed by 3 months of follow-up post procedure.

    3 months

Secondary Outcomes (2)

  • Recurrence rate

    12 months

  • Voltage (A minimum and maximum range of voltage for safe and effective IRE)

    3 months

Other Outcomes (2)

  • Progress free disease (PFS)

    12 months

  • Overall survival (OS)

    36 months

Study Arms (3)

Group A

EXPERIMENTAL

irreversible electroporation with voltage in level A for renal tumors

Procedure: irreversible electroporation

Group B

EXPERIMENTAL

irreversible electroporation with voltage in level B for renal tumors

Procedure: irreversible electroporation

Group C

EXPERIMENTAL

irreversible electroporation with voltage in level C for renal tumors

Procedure: irreversible electroporation

Interventions

irreversible electroporationPROCEDURE

Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unresectable kidney tumors
  • patients refused surgical therapy
  • Karnofsky-index \>70%
  • Age ≥ 18 and ≤ 80 years
  • life expectancy ≥ 12 month
  • compliance of the patient taking part in a study
  • informed consent

You may not qualify if:

  • an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2
  • QT-interval \>550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
  • active infection or severe health interference, that make taking part in a study unfeasible
  • pregnancy, lactation period
  • general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
  • psychiatric disorders that make taking part in a study or giving informed consent unfeasible
  • haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
  • thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time \>50
  • untreated urinary retention
  • severe hepatic dysfunction
  • any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
  • taking part in another clinical study for renal tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Electroporation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical Techniques

Study Officials

  • Lizhi Niu, PHD

    Fuda Cancer Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 12, 2015

Study Start

January 1, 2015

Primary Completion

May 20, 2020

Study Completion

January 1, 2021

Last Updated

September 5, 2021

Record last verified: 2020-06

Locations

CN(1)