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Completed

NCT Number: NCT02376231

To Evaluate Plasmajet in Achieving Complete Cytoreduction of Advanced EOC- Initial Feasibility Study

Surgery for ovarian cancer involves a big cut on your tummy (abdomen) followed by removal of pelvic organs (womb, tubes and ovaries), abdominal organs (fat tissue {omentum}, appendix) and any other tissues involved with cancer. Several studies worldwide have reported that women survive longer and enjoy a longer disease free interval before their disease returns if all visible disease is removed at the time of their surgery. Achieving this is not easy and often there is widespread disease and the surgeons are unable to remove every tumour nodule present as it is attached to the surface of the bowel, diaphragm and other important Extensive surgery with prolonged operating is associated with higher risks. Plasma energy is commonly referred to as the 4th state of matter after solid, liquid and gas. When a gas is heated, it partially or wholly ionizes resulting in high energy particles like ions, electrons and atoms referred to as 'plasma'. PlasmaJet® (PJ) is a new device which uses fine jet of neutral argon plasma from the handpiece that has been shown to have the ability to vaporise nodules close to sensitive organs like the bowel. It may offer the potential to treat the tumour nodules close to sensitive areas like the bowel. There have been no studies exploring its role in vaporising tumour nodules and its impact on survival. The PJ may be used by the surgeon to seal bleeding tissues (coagulate) or to burn away thin layers of tissue (ablate) by vaporization. It is licensed for use to achieve effects of coagulation and ablation. It is similar to conventional surgical devices that are routinely used (called diathermy) to achieve these effects. The PJ however is slightly different in that it may also be used on tissue to vaporise tumour nodules in women with ovarian cancer during surgery though the full extent of this role remains unclear.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient choice
  • Patient unfit for any treatment modality
  • Patients who are medically unfit for surgery and would only be suitable for chemotherapy.

WITHDRAWAL CRITERIA

  • Unforeseen complications in the individual patient will be recorded and then analysed.
  • Life threatening situation to the patient, due to any other unrelated complication.
  • Patients are free to withdraw from the study at any time with no impact on their care whatsoever.

Treatment and study plan

Surgery for EOC with trial (PJ) device (PlasmaJet)

Device

Debulking surgery for EOC using PJ device

Other names: PlasmaJet device

Primary outcomes

  1. Ability to achieve complete cytoreduction (nil macroscopic residual disease) either with current standard surgery or using PJ.

    Time frame: At surgery

Secondary outcomes

  1. Per-operative morbidity

    Time frame: 30 days

  2. Post-operative morbidity

    Time frame: 30 days

  3. Bowel resection rate

    Time frame: 6months

  4. Stoma formation rate

    Time frame: 6 months

  5. Disease Free Survival

    Time frame: 3years

  6. Overall Survival

    Time frame: 5 years

  7. Quality of Life

    Time frame: 3 years

    Quality of life based on validated EORTC questionnaires

  8. Cost-effectiveness

    Time frame: 3years

    Measured as an incremental cost per Quality of Life Year (QALY)

Sponsors and collaborators

Lead sponsor

Dr Thumuluru Kavitha Madhuri

Other

Registry information

Official study title

A Pilot Single Blinded Randomized Controlled Trial 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

Acronym: PJEOC

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Mar 3, 2015
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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