STING MARK Universal Fiducial Marker System

Официальное название

An Ex-Vivo Human Model Study for Proof of Concept, Usability, Reproducibility, Radio-Opacity and Marker Retention

Обзор

Currently available fiducial marker and fiducial insertion strategies are rudimentary, imprecise, not compatible with multiple insertion catheters/needles and are overall unreliable. STING-MARK device is the first universal, fully detachable and non-premounted radiopaque fiducial device system. Allowing biopsy prior to insertion, STING-MARK is easily and reliably delivered through-the-needle to the tumor, in order to accurately pinpoint its location for image-guided therapies. This study aims at establishing proof of concept for STING-MARK, by demonstrating its usability, reproducibility, radio-opacity and retention in a variety of clinically-relevant ex vivo organ samples.

Подробное описание

Patients undergoing surgical resection of solid organs at the CHUM or recipients of solid organ transplantation will be approached for consent into the study protocol. Human solid organs that are being removed for either elective surgery or transplantation will be removed in the standard manner and sent to the pathology laboratory as in the typical situation following removal. After the pathology team finishes with the organ, excess organ will be given to the research team for experimentation. In cases of recipient organs being removed for transplantation, they will be preserved in a plastic bag and then placed in the refrigerator. All experimentation will take place in the CRCHUM TID lab or Room 13 of the CHUM operating room.

Device insertion will occur with the designated needles and through the appropriate organ-specific route and imaging guidance. Multiple STING-MARK fiducials will be inserted. Plain film x-rays in 3 planes of the organs with the marker inserted will be taken and recorded.

Following experimentation, the organs will be appropriately labelled and returned to the pathology laboratory at the CHUM.

Вмешательства

• Устройство Sting Mark Fiducial Marker
  Device insertion will occur with the designated needles and through the appropriate organ-specific route and imaging guidance. Multiple STING-MARK fiducials will be inserted. Plain film x-rays in 3 planes of the organs with the marker inserted will be taken and recorded.

Первичные конечные точки

• Gain experience with deployability of the device in multiple organs, through different needles and different routes of insertion (trans-cutaneous, endoscopic). [Срок оценки: Through study completion, an average of 1 year]
• Verify stability of the device once inserted. [Срок оценки: Through study completion, an average of 1 year]
• verify radio-opacity of the device following insertion. [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (1)

• User feedback regarding usability of the device [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Patients undergoing surgical resection of solid organs
• Recipients of solid organ transplantation

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Канада · 1 центр

• CHUM — Montreal

Идентификаторы

NCT: NCT05465161 · CE 21.203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗