Trial · NCT07575191
Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer
NCT07575191, Phase 1, Phase 2, Recruiting, Smartwise Sweden AB
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer. Trials, record NCT07575191. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07575191
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer
- NCT number
- NCT07575191
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, estimated
- Lead sponsor
- Smartwise Sweden AB
- Conditions
- Pancreatic Cancer Non-resectable
- Interventions
- Gemcitabine, Extroducer Infusion Catheter System
- First posted
- 2026-05-08
- Last updated
- 2026-06-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Extroducer® related Serious Adverse Events | From each study treatment until 72 hours post treatment. | Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine. |
| Secondary | Gemcitabine related Serious Adverse Events | From first study treatment on Day 0 until study completion, ~8 Months. | Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion. |
| Secondary | Overall Survival | Through study completion, ~8 Months. | Overall Survival (OS) at 6 months after final Extroducer® treatment infusion with Gemcitabine. |
| Secondary | Progression Free Survival | Through study completion, ~8 Months. | Progression Free Survival (PFS) at 6 months after final Extroducer® treatment infusion with Gemcitabine. |
| Secondary | Tumor resectability | Through study completion, ~8 Months. | Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine. |
| Secondary | Tumor response | Through study completion, ~8 Months. | Classification of tumor response according to RECIST before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine. |
| Secondary | Tumor marker | Through study completion, ~8 Months. | Evaluation of the tumor marker CA-19-9 before (baseline) and after (Visits 9, 11-13) Extroducer® treatment infusion with Gemcitabine. |
| Secondary | Patient Quality of Life | Through study completion, ~8 Months. | Evaluation of subjects' quality of life using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items) and EORTC PAN26 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26) questionnaires before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine. All scales and single-item measures are scored from 1 to 100. Higher scores indicate a higher level of the measured construct. For functional scales, a higher score represents better or healthier functioning. A higher score on the Global Health Status/Quality of Life scale indicates better quality of life, whereas a higher score on symptom scales or items reflects a greater level of symptoms or problems. The two questionnaires are intended to be used together as a single module and therefore constitute one combined outcome measure. |
| Secondary | Incidence of Adverse Events and Device Deficiencies | Through study completion, ~8 Months. | The incidence, severity, and seriousness of Adverse Events and Device Deficiencies throughout the clinical investigation. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07575191
GET https://conductscience.org/api/trials/v1/NCT07575191/registered