A pilot randomised controlled trial to evaluate the utility and efficacy of neutral argon plasma (PlasmaJet®) as a new technology in achieving complete debulking of advanced Epithelial Ovarian Cancer

A pilot, randomised single blind study to evaluate the utility and efficacy of neutral argon plasma as a new technology in achieving complete cytoreduction of advanced epithelial ovarian carcinoma - initial feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26261491

Enrollment

150

Registered

2014-05-27

Start date

2013-03-01

Completion date

Unknown

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced (Stage 3/4) Epithelial Ovarian Cancer Cancer Ovarian Cancer

Interventions

This is a initial feasibility pilot RCT. Each participant may be randomised to PJ vs No PJ at the time of their debulking surgery. Each participant will then be followed up for at least the next 5 yea

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Imaging+/- Clinical +/- laparoscopic e/o pelvic mass and metastatic disease (FIGO III/IV disease) at presentation 2. Confirmation of malignancy on histological/cytological criteria 3. All women aged 18 or over with newly diagnosed FIGO stage III to Stage IV EOC undergoing surgical treatment 4. All women fit to undergo treatment 5. No synchronous malignancy likely to interfere with comparisons 6. Written and informed patient consent

Exclusion criteria

Exclusion criteria: 1. Patient choice 2. Patient unfit for any treatment modality 3. Patients who are medically unfit for surgery and would only be suitable for chemotherapy

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the ability to achieve complete cytoreduction (nil macroscopic residual). To evaluate the ability of PJ to achieve optimal cytoreduction (nil visible disease) in women undergoing open debulking surgery for EOC	—

Secondary

Measure	Time frame
1. To explore if achieving optimal cytoreduction helps increase disease free interval and hence improve survival 2. To categorise the histopathological effects of the depth of tumour destruction of metastatic EOC using the PJ 3. Evaluate the depth of tissue damage caused with a range of power settings and interaction times in vitro following surgery 4. To document the side-effect profile post-operatively following extensive surgery 5. Collate patient reported outcome measures using a validated tool	—

Measure

Time frame

1. To explore if achieving optimal cytoreduction helps increase disease free interval and hence improve survival 2. To categorise the histopathological effects of the depth of tumour destruction of metastatic EOC using the PJ 3. Evaluate the depth of tissue damage caused with a range of power settings and interaction times in vitro following surgery 4. To document the side-effect profile post-operatively following extensive surgery 5. Collate patient reported outcome measures using a validated tool

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026