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

NCT ID: NCT02376231

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Surgery without trial (PJ) device

Standard debulking surgery for EOC without interventional device

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgery with trial (PJ) device

Debulking surgery for EOC with interventional trial device (PJ)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Debulking surgery for EOC using PJ device

Interventions

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

Debulking surgery for EOC using PJ device

Intervention Type: DEVICE

Other Intervention Names

PlasmaJet device

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr Thumuluru Kavitha Madhuri

OTHER

Sponsor Role: lead

Responsible Party

Dr Thumuluru Kavitha Madhuri

Clinical Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Gynaecological Oncology, Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

PJEOCRSCH

Identifier Type: -

Identifier Source: org_study_id