NCT05133141终止不适用
A Prospective, Single-Arm, Multi-Center Study of the ECHELON ContourTM Curved Cutter Stapler Device in Colorectal Procedures
Ethicon Endo-Surgery2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Participants with Echelon Contour Success
研究概览
简要总结
The purpose of this study is to prospectively generate device-specific clinical data related to the performance of Echelon Contour per its instructions for use (IFU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective colorectal procedure where Echelon Contour is planned to be used for transection and resection of the colon
- •Willingness to give consent and comply with all study-related evaluations and visit schedule. If the participant is less than (<) 18 years of age, the participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide written Informed Consent for the participant. In addition, assent must be obtained from pediatric participants who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric participant is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study); the parent/legal guardian's written Informed Consent for the participant will be acceptable for the participant to be included in the study
- •Anatomical region must be of sufficient size for the device to be used
排除标准
- •Preoperative
- •Females who are pregnant
- •Physical or psychological condition which would impair study participation
- •Participant previously enrolled into the study (example: participant enrolled for Hartmann's procedure then cannot be reenrolled for the Hartmann's reversal)
- •Intraoperative
- •Study device use not attempted
结局指标
主要结局
Number of Participants with Echelon Contour Success
时间窗: interoperative
Echelon Contour success based on surgeon responses on question 1 in the surgeon reported outcome measures (SROM) will be reported. Surgeon will be asked to choose option "Yes" or "No" for following question: Did Echelon Contour provide acceptable performance considering other therapeutic alternatives?
次要结局
- Number of Participants with Device-related Adverse Events (AEs)(28 days post-procedure)
研究者
研究点 (2)
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