## Protocol Section
### Identification Module
**NCT ID:** NCT02430779

**Acronym:** IRE

**Brief Title:** Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms

**Official Title:** Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms: Phase I and Phase II Clinical Trial

#### Organization Study ID Info
**ID:** pelvis ureter Neoplasms-IRE-01
#### Organization
**Class:** OTHER
**Full Name:** Fuda Cancer Hospital, Guangzhou
### Status Module
#### Completion Date
**Date:** 2021-01-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-05

**Type:** ACTUAL

**Last Update Submit Date:** 2021-09-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2015-04-30
**Type:** ESTIMATED
**Study First Submit Date:** 2015-04-26
**Study First Submit QC Date:** 2015-04-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fuda Cancer Hospital, Guangzhou

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.

**Detailed Description:** By enrolling patients with unresectable Renal Pelvic and Ureteral 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 Renal Pelvic and Ureteral Neoplasms.

### Conditions Module

**Conditions:**

- Renal Pelvic and Ureteral Neoplasms

**Keywords:**

- irreversible electroporation

- Unresectable Renal Pelvic and Ureteral Neoplasms

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** irreversible electroporation for Unresectable Renal Pelvic and Ureteral Neoplasms

**Intervention Names:**

- Procedure: rreversible electroporation (IRE)

- Device: NanoKnife

**Label:** IRE Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The patients without treatment

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IRE Group

**Description:** Irreversible Electroportion For Unresectable Renal Pelvic and Ureteral Neoplasms guide with ultrasound or/and CT.

**Name:** rreversible electroporation (IRE)

**Other Names:**

- NanoKnife

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- IRE Group

**Name:** NanoKnife

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of participants with Adverse events

**Time Frame:** 6 month

#### Secondary Outcomes

**Measure:** Percentage of lesions that show no sign of recurrence 12 months after IRE

**Time Frame:** 12 months

**Description:** A minimum and maximum range of voltage for safe and effective IRE will be

**Measure:** Voltage (A minimum and maximum range of voltage for safe and effective IRE)

**Time Frame:** 3 months

**Measure:** Progress free disease (PFS)

**Time Frame:** 12 months

**Description:** Patients will be followed for 36 months after IRE for OS analyzed.

**Measure:** Overall survival (OS)

**Time Frame:** 36 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Renal Pelvic and Ureteral 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.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Biological treatment center in Fuda cancer hospital

**State:** Guangdong

**Zip:** 510000

#### Overall Officials

**Official 1:**

**Affiliation:** Fuda Cancer Hospital

**Name:** Lizhi Niu, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000014515

- Term: Ureteral Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17266

- Name: Ureteral Neoplasms

- Relevance: HIGH

- As Found: Ureteral Neoplasms

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M17265

- Name: Ureteral Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000014516

- Term: Ureteral Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
