Colon AdenocarcinomaPhase 2NCT06017141
Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
A Phase 2 study testing Biospecimen Collection, Electronic Health Record Review and Fentanyl Citrate in people with Colon Adenocarcinoma, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenocarcinoma
- What is being tested?
- Biospecimen Collection, Electronic Health Record Review and Fentanyl Citrate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 22 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age >= 18 years on day of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- Patients undergoing resection for biopsy proven colon adenocarcinoma
- Medically fit for colon resection
- Ability to complete required study questionnaires
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Diagnosis of rectal adenocarcinoma
- Simultaneously enrolled in any therapeutic clinical trial. Subsequent enrollment in an adjuvant therapy clinical trial is not automatically prohibited by this trial. Trial eligibility for subsequent studies will be determined by the VIVA principal investigator (PI) and the PI of the other clinical trial in question
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Active grade 3 (per the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
- Prisoner status
- Allergies to eggs, egg products, soybeans, or soy products (relative or absolute contraindication to propofol)
Show all 10Show fewer
- Personal or first degree relative with a history of malignant hyperthermia (absolute contraindication to inhaled volatile anesthetics)
- Diagnosis of inflammatory bowel disease
- Planned multi-visceral resection (examples include: pelvic exenteration, combined liver and colon resection)
- Patients undergoing resection for unresectable polyps, or incomplete polypectomies without biopsy proven adenocarcinoma are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Luke V. Selby, 913-588-7750, lselby@kumc.edu
Luke V. Selby
About this study
Official title: VIVA: Volatile or IV Anesthesia for Cancer
This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the differential impact of TIVA versus inhaled anesthesia on neutrophil extracellular traps (NET) inflammation and immunosuppression among patients undergoing cancer surgery.
SECONDARY OBJECTIVES:
- To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on patient reported post-operative recovery:
Ia. Overall, and domain-specific post-operative recovery (as measured by the Quality of Recovery Score [QoR]-40) on the day of discharge and other post-operative timepoints; Ib. Changes in overall and domain-specific post-operative recovery over time.
II. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on peri-operative clinical and anesthetic outcomes, as recorded in the electronic medical record (EMR), including:
IIa. Post-operative nausea and vomiting (from medical record); IIb. Post-operative pain (measured on a 1-10 scale) (from medical record); IIc. Return of gastrointestinal (GI) function (from medical record); IId. Post-operative cognitive impairment (from medical record); IIe. 30 and 90 days post-operative complications; IIf. Disease-free survival (from medical record); IIg. Overall survival (from medical record). III. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on circulating levels of inflammatory cytokines, immune cell populations, global inflammatory markers.
IV. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on levels of circulating tumor DNA (ctDNA) at multiple post-operative timepoints according to standard of care practices of the University of Kansas Medical Center (KUMC) Division of Medical Oncology GI oncology practice.
- Correlation of peri-operative clinical and anesthetic outcomes to neutrophil extracellular traps (NET) levels, measures of immune suppression, ctDNA.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care (SOC) sedation with sevoflurane via inhalation and fentanyl intravenously (IV) on study prior to SOC surgery. Some patients may also receive sedation with propofol IV prior to surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
ARM II: Patients receive SOC sedation with fentanyl IV and propofol IV on study prior to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
After completion of study treatment, patients are followed up at 1 and 3 days, 3 and 6 weeks, 3 and 6 months, and then yearly for 5 years from SOC surgery.
- Conditions
- Colon Adenocarcinoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review, Fentanyl Citrate, Propofol, Questionnaire Administration
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and tissue sample collection
Electronic Health Record ReviewOther
Ancillary studies
Fentanyl CitrateDrug
Also called Actiq, Fentanyl, Fentyl, Oralet
Given via injection
PropofolDrug
Also called Diprivan
Given IV
Questionnaire AdministrationOther
Ancillary studies
SevofluraneDrug
Also called Ultane
Given via inhalation
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo SOC surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (sevoflurane, fentanyl citrate, propofol) | Active comparator | Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Fentanyl Citrate; Drug: Propofol; Other: Questionnaire Administration; Drug: Sevoflurane; Procedure: Surgical Procedure |
| Arm II (fentanyl citrate, propofol) | Experimental | Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Fentanyl Citrate; Drug: Propofol; Other: Questionnaire Administration; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil extracellular traps (NET) formation
The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.
Measured: Post-operative day (POD) 1 to POD 6 months
Secondary outcomes (13)
Early post-operative recovery
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero until the time you are discharged from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Global and post-operative recovery
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero, Day One Post-Operative, Day Three Post Operative, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.
Measured: Post-Operative Day 0 to 6 months post-operatively
Post-operative nausea scores
The post operative nausea scores will be assessed using standardized nursing assessments captured in the patient's medical record. These scores will be evaluated starting at Post-Operative Day Zero until patient discharge from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Number and cumulative amount of doses of anti-emetics
The number and amount of doses of antiemetics will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Total hospital opioid use
The patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Patient-reported pain scores
The patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Number of times a pro re nata (PRN) medication administered
The number of times a patient is administered medication PRN (as needed) will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
First post-op day when participant tolerates a regular diet (at the discretion of the surgical team)
The first day when the patient is able to tolerate a regular diet. This will occur between Post-Operative Day Zero and the time they are discharged from the hospital.
Measured: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Time from study entry and from surgery to disease recurrence, death, or loss to follow up
The length of time the patient is on the study and the time from surgery to either the cancer returning, the patient passing away, or the loss contact with the patient starting at Post-Operative Day Zero through the duration on the study (up to five years) unless the patient's disease returns, they pass away, or the study team loses contact with them.
Measured: Post-Operative Day 0 up to Five Years Post-Operation
Post-operative complications
Complications will be assessed via the patients' medical record, and the Clavien-Dindo classification system which includes the comprehensive complication index. The Clavien-Dindo classification system consists of complication index consists of the of the following grades: I, II, IIIa, IIIb, IVa, IVb, V. Post-operative complications will be assessed Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative.
Measured: Post-Operative Day 0 to Three Months Post-Operatively
Post-operative immune suppression
Will be assessed by the notes in the patients' medical records and the biomarkers collected in the research blood tests. Post-operative immune suppression will be evaluated Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.
Measured: Post-Operative Day 1 to 6 months Post-Operatively
Circulating tumor deoxyribonucleic acid (ctDNA)
Will be assessed by blood tests using commercially available, FDA approved, assays according to the standard practices of the University of Kansas Cancer Center (KUMC) Division of Medical Oncology GI Oncology Group. Differences between groups will be compared using regression based and/or non-parametric analyses as appropriate.
Measured: Post-Operative Day 0 up to 5 years
Changes in gene expression
RNA sequencing of resected tumors will be used to investigate differences in gene expression by anesthesia type.
Measured: Immediately post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start22 May 2023
- Primary completion22 May 2025 (estimated)
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Luke Selby, University of Kansas Medical Center
- Investigators
- Luke V Selby, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017141
- Sponsor's protocol ID
- STUDY00149314
- Other IDs
- NCI-2023-05587, IIT-2022-VIVA, STUDY00149314, P30CA168524
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 30 Aug 2023
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIVA: Volatile or IV Anesthesia for Cancer
- ClinicalTrials.gov ID
- NCT06017141
- Acronym / sponsor ID
- STUDY00149314
- Conditions
- Colon Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 22 May 2025 (estimated)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 30 Aug 2023 (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.
This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the differential impact of TIVA versus inhaled anesthesia on neutrophil extracellular traps (NET) inflammation and immunosuppression among patients undergoing cancer surgery.
SECONDARY OBJECTIVES:
- To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on patient reported post-operative recovery:
Ia. Overall, and domain-specific post-operative recovery (as measured by the Quality of Recovery Score [QoR]-40) on the day of discharge and other post-operative timepoints; Ib. Changes in overall and domain-specific post-operative recovery over time.
II. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on peri-operative clinical and anesthetic outcomes, as recorded in the electronic medical record (EMR), including:
IIa. Post-operative nausea and vomiting (from medical record); IIb. Post-operative pain (measured on a 1-10 scale) (from medical record); IIc. Return of gastrointestinal (GI) function (from medical record); IId. Post-operative cognitive impairment (from medical record); IIe. 30 and 90 days post-operative complications; IIf. Disease-free survival (from medical record); IIg. Overall survival (from medical record). III. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on circulating levels of inflammatory cytokines, immune cell populations, global inflammatory markers.
IV. To evaluate the differential impact of TIVA versus inhaled total anesthesia choice on levels of circulating tumor DNA (ctDNA) at multiple post-operative timepoints according to standard of care practices of the University of Kansas Medical Center (KUMC) Division of Medical Oncology GI oncology practice.
- Correlation of peri-operative clinical and anesthetic outcomes to neutrophil extracellular traps (NET) levels, measures of immune suppression, ctDNA.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care (SOC) sedation with sevoflurane via inhalation and fentanyl intravenously (IV) on study prior to SOC surgery. Some patients may also receive sedation with propofol IV prior to surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
ARM II: Patients receive SOC sedation with fentanyl IV and propofol IV on study prior to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
After completion of study treatment, patients are followed up at 1 and 3 days, 3 and 6 weeks, 3 and 6 months, and then yearly for 5 years from SOC surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (sevoflurane, fentanyl citrate, propofol) | Active comparator | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Drug: Fentanyl Citrate, Drug: Propofol, Other: Questionnaire Administration, Drug: Sevoflurane, Procedure: Surgical ProcedurePatients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery. |
| Arm II (fentanyl citrate, propofol) | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Drug: Fentanyl Citrate, Drug: Propofol, Other: Questionnaire Administration, Procedure: Surgical ProcedurePatients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age >= 18 years on day of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- Patients undergoing resection for biopsy proven colon adenocarcinoma
- Medically fit for colon resection
Key exclusion criteria (10 listed)
- Diagnosis of rectal adenocarcinoma
- Simultaneously enrolled in any therapeutic clinical trial. Subsequent enrollment in an adjuvant therapy clinical trial is not automatically prohibited by this trial. Trial eligibility for subsequent studies will be determined by the VIVA principal investigator (PI) and the PI of the other clinical trial in question
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Active grade 3 (per the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
- Prisoner status
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood and tissue sample collection | Procedure or surgery | Arm I (sevoflurane, fentanyl citrate, propofol), Arm II (fentanyl citrate, propofol) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (sevoflurane, fentanyl citrate, propofol), Arm II (fentanyl citrate, propofol) |
| Fentanyl CitrateAlso: Actiq, Fentanyl, Fentyl, OraletGiven via injection | Drug | Arm I (sevoflurane, fentanyl citrate, propofol), Arm II (fentanyl citrate, propofol) |
| PropofolAlso: DiprivanGiven IV | Drug | Arm I (sevoflurane, fentanyl citrate, propofol), Arm II (fentanyl citrate, propofol) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (sevoflurane, fentanyl citrate, propofol), Arm II (fentanyl citrate, propofol) |
| SevofluraneAlso: UltaneGiven via inhalation | Drug | Arm I (sevoflurane, fentanyl citrate, propofol) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo SOC surgery | Procedure or surgery | Arm I (sevoflurane, fentanyl citrate, propofol), Arm II (fentanyl citrate, propofol) |
Primary outcome
Neutrophil extracellular traps (NET) formation
Time frame: Post-operative day (POD) 1 to POD 6 months
The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.
13 secondary outcomes
Early post-operative recovery
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Global and post-operative recovery
Time frame: Post-Operative Day 0 to 6 months post-operatively
Post-operative nausea scores
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Number and cumulative amount of doses of anti-emetics
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Total hospital opioid use
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Patient-reported pain scores
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Number of times a pro re nata (PRN) medication administered
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
First post-op day when participant tolerates a regular diet (at the discretion of the surgical team)
Time frame: Post-Operative Day 0 to post-operative discharge, approximately 2-4 days
Time from study entry and from surgery to disease recurrence, death, or loss to follow up
Time frame: Post-Operative Day 0 up to Five Years Post-Operation
Post-operative complications
Time frame: Post-Operative Day 0 to Three Months Post-Operatively
Post-operative immune suppression
Time frame: Post-Operative Day 1 to 6 months Post-Operatively
Circulating tumor deoxyribonucleic acid (ctDNA)
Time frame: Post-Operative Day 0 up to 5 years
Changes in gene expression
Time frame: Immediately post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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. This study is not recruiting at the moment.
Luke V Selby principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Electronic Health Record Review and Fentanyl Citrate in people with Colon Adenocarcinoma, run by University of Kansas Medical Center at 1 site in United States.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil extracellular traps (NET) formation (time frame: Post-operative day (POD) 1 to POD 6 months). 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 30 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.