Cold Atmospheric Plasma (CAP)NCT06796634
Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue
A study testing J-plasma in people with Cold Atmospheric Plasma (CAP) and J-Plasma, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Atmospheric Plasma (CAP), J-Plasma, Peritoneal Tumor
- What is being tested?
- J-plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Aug 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origin. Potential cancer types include ovarian cancer, colorectal cancer, and malignant peritoneal mesothelioma
- Written informed consent
- Age ≥ 18 years.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Ghent
Ghent, East-Flanders, 9000
Wim Ceelen, MD, PhD, Prof, +3293326251, wim.ceelen@ugent.be
Sarah Cosyns, sarah.cosyns@ugent.be
About this study
There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.
- Conditions
- Cold Atmospheric Plasma (CAP), J-Plasma, Peritoneal Tumor
- Being tested
- J-plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-plasmaDevice
- Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP.
- Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations:
- 15 W, 30W, or 45W
- 2, 5, or 10 seconds.
- The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry.
| Study group | Role | What they receive |
|---|---|---|
| Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origi | Experimental | * Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP.
* Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations:
* 15 W, 30W, or 45W
* 2, 5, or 10 seconds.
* The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry. Receives: Device: J-plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Histology:
Following resection, FFPE sections will be assessed morphologically, particularly for the extent of tumor necrosis using haematoxylin and eosin staining. IHC staining will be performed to investigate mechanisms of autophagia (p62 and LC3B), apoptosis (cleaved caspase 3) and proliferation (ki67).
- Extent of tumor necrosis: morphological assessment
- Proliferation: Ki67 via MIB1
- Autophagia: p62 or LC3B
- Apoptosis: Caspase 3 antibodies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start21 Aug 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold Atmospheric Plasma (CAP)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796634
- Sponsor's protocol ID
- ONZ-2024-0090
- Other IDs
- B6702024000142
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue
- ClinicalTrials.gov ID
- NCT06796634
- Acronym / sponsor ID
- ONZ-2024-0090
- Conditions
- Cold Atmospheric Plasma (CAP), J-Plasma, Peritoneal Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origi | Experimental | Device: J-plasma* Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP. * Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations: * 15 W, 30W, or 45W * 2, 5, or 10 seconds. * The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origin. Potential cancer types include ovarian cancer, colorectal cancer, and malignant peritoneal mesothelioma
- Written informed consent
- Age ≥ 18 years.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| J-plasma* Surgery and application of CAP: at the start of surgery, an inventory is made of suitable tumor nodules that will be planned for resection. Nodules should have a maximal size of 2-3 mm, since it is unlikely that bigger lesions can be adequately treated with CAP. * Selected tumor nodules will be treated with the J-plasma device at the standard settings (Helium gas flow of 4 l/min, coagulation and cutting intensity at 35). The distance between the tip of the device and the tissue will be approx. 10 mm. Using a timer and footswitch, nodules will be treated at different power settings and durations: * 15 W, 30W, or 45W * 2, 5, or 10 seconds. * The treated nodules will be resected at least 30 minutes after plasma treatment, and the exact timing will be documented. The samples are split in half: one half is fixed in formalin for histology and immune histochemistry, and the other half is immediately processed for live/death staining using flow cytometry. | Device | Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origi |
Primary outcome
- Histology:
Time frame: 1 year
Following resection, FFPE sections will be assessed morphologically, particularly for the extent of tumor necrosis using haematoxylin and eosin staining. IHC staining will be performed to investigate mechanisms of autophagia (p62 and LC3B), apoptosis (cleaved caspase 3) and proliferation (ki67). * Extent of tumor necrosis: morphological assessment * Proliferation: Ki67 via MIB1 * Autophagia: p62 or LC3B * Apoptosis: Caspase 3 antibodies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
Related trials for Cold Atmospheric Plasma (CAP)
Not yet recruiting
Evaluation of Cold Plasma in Chronic Wound Healing
Chronic Wounds, Venous Leg Ulcer (VLU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J-plasma in people with Cold Atmospheric Plasma (CAP) and J-Plasma, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wim Ceelen, professor (+3293326251, wim.ceelen@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Histology: (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.