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Trial · NCT04276090

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercent Completion of 1st Cycle of Hepatic Artery Chemotherapyapproximately 4 weeks
The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
Secondary30-day Postoperative Serious Adverse Events Related to Pump Implantation30 daysTabulation of CTCAE serious adverse events attributed to pump implantation
Secondary30-day Catheter Malfunction Due to Tubing Disconnect30 daysQuantify the percent of patients with inability to meet primary outcome due to catheter disconnects.
Secondary30-day Catheter Malfunction Due to Inability to Access Pump30 daysQuantify the percent of patients with inability to meet primary outcome due to inability to access pump.
SecondaryPercent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.Approximately 4 weeksPercentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.
SecondaryPercent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.Immediate, determined at screening visitPatients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.
SecondaryPercent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.Approximately 6 monthsPercent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.
SecondaryNumber of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.6 monthsThe number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.
SecondaryPercent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.3 monthsThe percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.
SecondaryOverall Response Rate at 6 Months6 monthsRECIST v1.1 will be used to assess overall response rate at 6 months.
SecondaryPercent of Patients Who Are Downstaged and Undergo Surgery6 monthsThe percent of patients who are downstaged and undergo surgery will be tabulated.
SecondaryPercent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.6 monthsThe percentage of patients who remain on pump chemotherapy at 6months will be tabulated.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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