NCT01647906已完成不适用
A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 20
- 主要终点
- Freedom from fecal incontinence reintervention
研究概览
简要总结
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
详细描述
This observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient will be eligible for study participation if he/she meets the following criteria:
- •Able to fluently speak and understand the language in which the study is being conducted and able to provide meaningful written informed consent for the study.
- •Have FI, have failed conservative therapy (e.g., diet, fiber therapy, medications that treat diarrhea), and are scheduled to receive Solesta treatment.
- •Females must be of non-childbearing potential; or females of childbearing (reproductive) potential must agree to use an acceptable method of contraception for at least the first 6 months of study participation and have a negative urine pregnancy test at Visit 1 (Screening/Baseline) and immediately prior to receiving initial Solesta treatment. Women who are surgically sterile or those who are post menopausal for at least 2 years prior to entering the study are not considered to be of childbearing potential.
- •Willing to return to the study facility for the post treatment evaluation.
排除标准
- •A patient will be excluded from the study if he/she meets any of the following criteria:
- •Is currently pregnant, breastfeeding, or is planning to become pregnant over the course of the study.
- •Has an active inflammatory bowel disease.
- •Has an immunodeficiency disorder or ongoing immunosuppressive therapy.
- •Has received previous radiation treatment to the pelvic area.
- •Has significant mucosal or full thickness rectal prolapse.
- •Has active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections.
- •Has anorectal atresia, tumors, stenosis or malformation.
- •Has a rectocele.
- •Has rectal varices.
- •Has presence of existing implant including Solesta, artificial bowel sphincter, or sacral nerve stimulator (activated or inactivated).
- •Has an allergy to hyaluronic acid (HA) based products.
- •Has an anastomosis to the rectum or anus within 10 cm of the dentate line.
- •Has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the requirements of the post-approval study protocol.
- •Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
- •Has undergone sphincteroplasty, graciloplasty, or other surgical interventions (without the use of an implanted device) for treatment of fecal incontinence within 12 months of enrollment.
- •Has any bleeding disorder.
结局指标
主要结局
Freedom from fecal incontinence reintervention
时间窗: Through 36 months after the last Solesta treatment
The primary effectiveness endpoint is freedom from Fecal Incontinence Reintervention. Patients will be evaluated at 3, 6, 12, 24, and 36 months after the last Solesta treatment for the occurrence (or lack of occurrence) of Fecal Incontinence Reintervention. Fecal Incontinence Reintervention includes Fecal Incontinence treatment of sphincteroplasty, implantation of artificial bowel sphincter, retreatment with Solesta, graciloplasty, sacral nerve stimulation (SNS) or other surgical interventions that occur more than 3 months after the last primary Solesta treatment.
次要结局
- Anatomic stability of the Solesta(Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment.)
- Occurrence of any peri-injection device related infectious adverse events.(Assessed from time of injection up to 2 weeks after Solesta treatment)
- Global Perceived Effect Score(Assessed at 6, 12 and 36 months after last Solesta treatment)
- Time to Fecal Incontinence Reintervention(Assessed from 6 to 36 months after last Solesta treatment)
- Fecal Incontinence Quality of Life (FIQL)(Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment.)
- Cleveland Clinic Florida Fecal Incontinence Score (CCFIS)(Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
不适用
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)Coronary Artery DiseaseNCT02650128Shockwave Medical, Inc.60
终止
4 期
A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.Advanced Prostate CancerNCT03971110AstraZeneca9
终止
不适用
The Pristine Post-Market StudyHemodialysis ComplicationHemodialysis Catheter InfectionHemodialysis Access FailureCentral Venous Catheter Related Bloodstream InfectionEnd Stage Renal DiseaseKidney Failure, ChronicNCT05228132C. R. Bard142
已完成
不适用
Study to Evaluate the Safety and Effectiveness of the RAP Device for the Improvement in the Appearance of CelluliteCelluliteNCT05199506Soliton15
招募中
不适用
Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain MetastasesNon-small Cell Lung Cancer MetastaticBrain MetastasesNCT05638425Xiangya Hospital of Central South University20