NCT06739031

Brief Summary

The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are:

  • Safety of PEF treatment of early-stage unreseectable NSCLC patients.
  • Locoregional control of ablated lesions.
  • Survival and quality of life assessment of early-stage unreseectable NSCLC patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Dec 2024Aug 2027

First Submitted

Initial submission to the registry

December 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

December 25, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2027

Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

December 9, 2024

Last Update Submit

December 16, 2024

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

  • 6-month complete ablation rate

    6 months

Secondary Outcomes (5)

  • Technical success rate

    immediately after the PEF ablation treatment

  • 6-month pulmonary progression-free survival rate

    6 months after the first PEF ablation treatment

  • 12-month complete ablation rate

    12 months after the first PEF ablation treatment

  • 12-month pulmonary progression-free survival rate

    12 months after the first PEF ablation treatment

  • 12-month overall survival rate

    12 months after the first PEF ablation treatment

Other Outcomes (1)

  • Safety of Intervention

    12 months

Study Arms (1)

PEF Treatment

EXPERIMENTAL
Device: PEF Treatment

Interventions

PEF TreatmentDEVICE

PEF Energy ablation of lung tumors

PEF Treatment

Eligibility Criteria

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

You may qualify if:

  • \. Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.

You may not qualify if:

  • The subject cannot tolerate or refuses general anesthesia;
  • Has a history of severe allergic reactions;
  • Has contraindications to bronchoscopy or refuses bronchoscopy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,

Shanghai, China

Location

Central Study Contacts

Sara Xu

CONTACT

021sara.xu@energenxmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 18, 2024

Study Start

December 25, 2024

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

August 25, 2027

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations

CN(1)