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NCT02902107 · ClinicalTrials.gov registry record · Phase 1
Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet
A Phase 1 study of Pelvic Malignancy and Abdominal Malignancy, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02902107: Completed Phase 1 study of Pelvic Malignancy and Abdominal Malignancy, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02902107 is a Phase 1 study of Pelvic Malignancy and Abdominal Malignancy that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02902107, a Phase 1 study of Pelvic Malignancy and Abdominal Malignancy, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will allow us to determine how feasible it is to implant the CivaSheet into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible side effects of the device. This study, if successful, may allow us to offer the CivaSheet more widely as treatment option to future patients.
Primary Outcome
Feasibility is determined by successful implantation of the device into a patient who has been enrolled on the protocol and deemed appropriate for IORT at the time of surgery.
Conditions Studied
Interventions
- RADIATION Brachytherapy
- DEVICE CivaSheet
- PROCEDURE surgical resection
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-09-09 |
| Est. Completion | 2024-10-17 |
| Phase | Phase 1 |
What the finished NCT02902107 record still lists
NCT02902107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Pelvic Malignancy appearing as the primary indexed condition, and to 3 interventions - of which Brachytherapy is the first listed.
NCT02902107 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02902107 about?
NCT02902107 is a clinical study titled "Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet". This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will ...
What is the current status of trial NCT02902107?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-09-09. Estimated completion is 2024-10-17.
What conditions does trial NCT02902107 study?
This clinical trial studies the following conditions: Pelvic Malignancy, Abdominal Malignancy.
What interventions are being tested in trial NCT02902107?
The interventions under investigation include: Brachytherapy (RADIATION), CivaSheet (DEVICE), surgical resection (PROCEDURE).
Who is sponsoring clinical trial NCT02902107?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02902107 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02902107's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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