A Randomized, Controlled, Subject and Reviewer-Blinded, Multi-Centre Study To Assess The Safety and Manageability Of LABS™ In Women Undergoing Gynaecologic Laparoscopic Surgery Followed By Second Look Laparoscopy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Incidence of adverse events, abnormal changes in vital signs and/or clinical laboratory measures
研究概览
简要总结
The purpose of this study is to obtain data on the safety and manageability of applying LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following laparoscopic gynaecologic surgery. In addition, performance data following a clinical indicated second look laparoscopy will be collected for the purpose of determining sample size predictions for future trials.
详细描述
Women undergoing laparoscopic uterine myomectomy, adhesiolysis, treatment of endometriosis or ovarian cystectomy with associated adhesions and/or endometriosis, and planned, clinically indicated second look laparoscopy within 4-12 weeks will be enrolled into one of two sub studies in which the major component of the surgery (as determined by the surgeon) was due to:
- Myomectomy Or
- Other Gynaecology Pathology (repeat myomectomy, adhesiolysis, and/or treatment of endometriosis, ovarian cystectomy with associated adhesions or endometriotic pathology, removal of adenomyoma without myomectomy.
The myomectomy sub study will include two arms:
- Pure Myomectomy -myomectomy with no endometriosis and no adhesions/few filmy uterine adhesions - blunt dissection only
- Hybrid Myomectomy - myomectomy with (+/-) adhesions and/or (+/-) endometriosis and/or (+/-) adenomyomectomy Patients in each sub study (1 or 2) and each arm of the myomectomy study (a or b) will be randomized to receive LABS™ following their laparoscopic surgery or current standard of care: surgery only control. All patients will be blinded to their treatment status until study completion.
Sub study and sub-group allocation as well as randomisation will occur once the initial laparoscopy is completed but before removal of the laparoscope. Myomectomy patients randomized to receive LABS™ will then have the device sprayed to the entire surface of the uterus and other areas of surgical trauma. In all treated patients all sites of surgical trauma should be completely covered with LABS™ allowing a sprayed margin of at least 3 cm around the operated or traumatised site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 46 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LABS™
hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma
干预措施: LABS™ (Device)
Surgical Control
Laproscopic Surgery Only
干预措施: Surgical Control (Procedure)
结局指标
主要结局
Incidence of adverse events, abnormal changes in vital signs and/or clinical laboratory measures
时间窗: Between baseline initial surgery and second look laparoscopy (4-12 weeks)
次要结局
- Surgeon satisfaction with the device and it's application(During baseline initial surgery)
