A prospective, open-label, single-arm, multicenter, post marketing surveillance study to evaluate safety and performance of MIRUSâ„¢Disposable Hemorrhoids Stapler in the treatment of prolapsed Hemorrhoids.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 9
- 主要终点
- - Post Operative Pain
研究概览
简要总结
This is a prospective, open-label, single-arm, multi-center, post marketing surveillance study to evaluate safety and performance of MIRUSâ„¢ Disposable Hemorrhoids Stapler in the treatment of prolapsed Hemorrhoids in minimum 80 subjects in India at approximately 5-10 centers.
The objective of the study is to evaluate safety and performance of Hemorrhoids Stapler for immediate and short-term postoperative outcomes at different time points [Time Frame: at Baseline, post procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)].
All eligible subjects based on inclusion/exclusion will be approached to sign Informed Consent Form (ICF) approved by respective Ethics Committee (EC) before starting the study related process. The subjects will be treated using MIRUS Hemorrhoids Stapler for prolapsed hemorrhoids as per the standard guidelines and practices. The subject will be kept on a standard regimen in post-operative and follow-up period. Subject’s clinical follow-up will be taken at 15 days (±7 days), 3 months (±28 days), 6 months (±28 days).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Each potential subject must satisfy all of the following criteria to be enrolled in the study:
- •Male and female subjects who are 18 to 80 years of age.
- •Those subjects with late grade II hemorrhoids and unlikely to respond to one or two sessions of rubber band ligation (RBL) and/or conservative treatment.
- •Subjects with grade III (prolapsing internal hemorrhoids requiring manual reduction) and/or grade IV (irreducible prolapse) are suitable candidate with stapled hemorrhoidopexy.
- •Subject must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •Subject must follow the post-operative follow-up visits for 6 months.
排除标准
- •Any potential subject who meets any of the following criteria will be excluded from participating in the study:
- •Any female subject, who is pregnant, suspected pregnancy at the time of screening.
- •Subject’s tissue thickness found to be less than 0.75mm or greater then 1.5mm, or where the internal diameter of the rectum will not be able to accommodate the instrument and accessories.
- •Subject’s tissue has undergone multiple injections of hardening agent at hemorrhoids.
- •The subject has a history of fecal incontinence.
- •The subject has an active or a history of infection requiring antibiotics at the intended operative site within 30 days prior to the planned surgery date.
- •The subject has a history of venous thrombosis or pulmonary embolism.
- •The subject has a history of coagulopathy.
- •The subject has taken aspirin, anti coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
- •The subject has existing anal stenosis/severe mucosal edema or any other co-morbidities which in the opinion of the investigator will not be appropriate for the study.
- •Subject undergone multiple injections in tissue, using hardening agents or with history of acutely prolapsed thrombosed piles associated anal fistulas (abnormal connection between anal canal & skin), anal fissures (anal ulcer), abscess (pus under the skin surrounding the anus) or rectal prolapse.
结局指标
主要结局
- Post Operative Pain
时间窗: At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)
- Number of AE/SAE related to study device during 6 month of study period.
时间窗: At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)
- Immediate postoperative complications and short term outcomes related to study device.
时间窗: At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)
次要结局
- 1. Incidence of Stapler Malfunction or Misfires(2. Operation Time)