Clinical trial · Interventional
Infusion System for Hepatic Cancer
Combined Infusion System to Deliver Chemotherapy Regionally to the Liver
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma. After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic to Liver | Cholangiocarcinoma | PROBABILISTIC | 0.70 |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hepatic Artery Infusion (HAI) Therapy
- description
- Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.
- interventionNames
- Device: Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)
Primary outcomes (1)
- measure
- Number of Targeted Adverse Events (TAEs)
- timeFrame
- From surgery up to 60 months post-surgery or study withdrawal
- description
- TAEs are defined as AEs deemed related to the combination of the devices (i.e., the connection between the Medtronic pump and Intera Catheter).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be greater than or equal to 18 years of age * Have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or intrahepatic cholangiocarcinoma * At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative HAI * Be deemed appropriate for pump chemotherapy by both a medical oncologist and a surgical oncologist * Provision of signed and dated informed consent form Exclusion Criteria: * Known active infection * Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
References
Publications (0)
Data not yet available