Pancreatic NeoplasmsNCT02591082
Intra-Arterial Treatment of Pancreatic Cancer Using the RenovoCath™ RC120 Catheter
An observational study of Pancreatic Neoplasms, run by RenovoRx at 5 sites in United States.
Trial summary
This is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- RenovoCath™ R120 Catheter
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2015to 26 Feb 2021
- Phase
- Observational
- 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
Study population: Patients diagnosed with unresectable or borderline resectable pancreatic cancer.
Who may be able to join
- 18 years of age
- Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology
- Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure
- Willing to provide informed consent and comply with the required follow-up.
Who cannot join
- Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.
- Currently participating in another active drug or device study or registry protocol that would interfere with this study.
- Vulnerable populations: prisoners, pregnant or breastfeeding females.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
East Carolina University
Greenville, North Carolina, 27834
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
Good Samaritan Hospital
San Jose, California, 95154
Florida Hospital
Tampa, Florida, 33613
Montefiore Hospital
The Bronx, New York, 10461
About this study
Official title: A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter
This is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.
Read the detailed description
This is an observational, registry study to assess patient survival and clinical outcomes of the RenovoCath™ RC120 catheter when used to deliver chemotherapeutic agents to pancreatic tumors. Blood samples will be drawn in a subset of patients to assess the systemic concentration of the chemotherapeutic agent.
The RenovoCath™ RC120 Catheter is an endovascular multi-lumen, two-handled catheter designed to isolate variable segments of arteries supplying the target organ using two slideable, compliant balloons. Upon inflation of the proximal occlusion balloon and the distal occlusion balloon, the catheter may isolate the selected site to specifically deliver radiopaque and therapeutic agents including, but not limited to chemotherapeutic drugs.
- Conditions
- Pancreatic Neoplasms
- Being tested
- RenovoCath™ R120 Catheter
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenovoCath™ R120 CatheterDevice
The RenovoCath™ RC120 Catheter will be used to isolate segments of arteries supplying blood to the pancreas. The two balloons on the catheter will be positioned and inflated to temporarily stop blood flow while medication is infused through the catheter between the balloons.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas
Measured: 2 Years
Secondary outcomes (1)
Tumor response
Time to tumor response in the primary site of application as assessed by imaging.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenovoRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramtin Agah, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591082
- Sponsor's protocol ID
- RR2
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2015
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hatoum H, Rosemurgy A 2nd, Bastidas JA, Zervos E, Muscarella P 2nd, Edil BH, Cynamon J, Johnson DT, Thomas C, Swinson BM, Nordgren A, Vitulli P, Nutting C, Gipson M, Tsobanoudis A, Agah R. Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2. Oncologist. 2024 Aug 5;29(8):690-698. doi: 10.1093/oncolo/oyae178.
PubMed 39049803
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter
- ClinicalTrials.gov ID
- NCT02591082
- Acronym / sponsor ID
- RR2
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- RenovoRxIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 29 Oct 2015 (estimated)
- 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 is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.
Detailed description
This is an observational, registry study to assess patient survival and clinical outcomes of the RenovoCath™ RC120 catheter when used to deliver chemotherapeutic agents to pancreatic tumors. Blood samples will be drawn in a subset of patients to assess the systemic concentration of the chemotherapeutic agent.
The RenovoCath™ RC120 Catheter is an endovascular multi-lumen, two-handled catheter designed to isolate variable segments of arteries supplying the target organ using two slideable, compliant balloons. Upon inflation of the proximal occlusion balloon and the distal occlusion balloon, the catheter may isolate the selected site to specifically deliver radiopaque and therapeutic agents including, but not limited to chemotherapeutic drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with unresectable or borderline resectable pancreatic cancer.
Key inclusion criteria (4 listed)
- 18 years of age
- Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology
- Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure
- Willing to provide informed consent and comply with the required follow-up.
Key exclusion criteria (3 listed)
- Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.
- Currently participating in another active drug or device study or registry protocol that would interfere with this study.
- Vulnerable populations: prisoners, pregnant or breastfeeding females.
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 |
|---|---|---|
| RenovoCath™ R120 CatheterThe RenovoCath™ RC120 Catheter will be used to isolate segments of arteries supplying blood to the pancreas. The two balloons on the catheter will be positioned and inflated to temporarily stop blood flow while medication is infused through the catheter between the balloons. | Device | – |
Primary outcome
Survival
Time frame: 2 Years
Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas
1 secondary outcome
Tumor response
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 39049803Hatoum H, Rosemurgy A 2nd, Bastidas JA, Zervos E, Muscarella P 2nd, Edil BH, Cynamon J, Johnson DT, Thomas C, Swinson BM, Nordgren A, Vitulli P, Nutting C, Gipson M, Tsobanoudis A, Agah R. Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2. Oncologist. 2024 Aug 5;29(8):690-698. doi: 10.1093/oncolo/oyae178.
- Individual participant dataSharing planned: No
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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.
Ramtin Agah, MD study director
Chief Medical Officer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by RenovoRx at 5 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591082, which also lists 1 linked publication.
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 20 Oct 2021.