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临床试验/NCT02260115
NCT02260115已完成1 期

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

Actamax Surgical Materials LLC4 个研究点 分布在 2 个国家目标入组 78 人开始时间: 2013年11月最近更新:
适应症
干预措施

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:

  1. Myomectomy Or
  2. 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:

  1. Pure Myomectomy -myomectomy with no endometriosis and no adhesions/few filmy uterine adhesions - blunt dissection only
  2. 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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

LABS™

Experimental

hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma

干预措施: LABS™ (Device)

Surgical Control

Sham Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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