2024-513306-65-00招募中2 期
Safety and potential effect of innovative treatment by adjuvant injection of stromal vascular Fraction from autologous adipose tissue of URethral stenosis with endoscopic urethrotomy: randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.
研究概览
简要总结
The main objective of this study is to assess the safety and tolerability of ADSVF, as add-on treatment to endoscopic urethrotomy for recurrent bulbar urethral stenosis during the follow-up.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male, aged from 18 to 85 years
- •Bulbar urethral stenosis ≤ 3 cm Although there is no concensus on a clear definition of what a significant bulbar UrS is to date, a significant Bulbar UrS will be defined as 3 dimension entity for the study: - A narrowing of urethra that does not accept a standard flexible fibroscope (CH16) to pass through - In a patient with bothersome voiding and/or storage symptoms or any complication (infection, retention) who is asking for a relief - Qmax ≤ 15 ml/s AND USP ICIQ male LUTS voiding dysfunction domain ≠ 0 (Zero)
- •At least one urethral dilatation or urthrotomy for the bulbar stenosis in the past 24 months before diagnosis of stenosis
- •Ability to avoid corticoids or immunosuppressive drugs one month after treatment
- •Good general health status according to clinical history and a physical examination
- •BMI > 18 to insure adequate access to abdominal or other subcutaneous adipose tissue for adipose tissue harvesting
排除标准
- •Urethral stenosis of other location than bulbar
- •Contraindication to the anaesthetic or surgical procedure
- •Corticoids or immunosuppressive drugs > 3 months
- •Any active viral infection among the following: HIV, HTLV I and II, VHB, VHC and Syphillis
- •Administrative restricted rights
- •Urethral stenosis length > 3 cm
- •Urethral stenosis on reconstructed penis (transgender, post amputation)
- •Prior perineal or pelvic radiotherapy
- •Concurent urinary tract infection without treatment
- •Concurent perineal infection
- •Penile cancer < 5 years
- •Current or recent history of abnormal, severe, progressive, uncontrolled infectious, hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease
- •Congenital or acquired immunodeficiencies
结局指标
主要结局
Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.
Safety endpoints will include the frequency and intensity of classic adverse events of urethrotomy: urethral bleeding, urinary infection, urethral pain (intensity and duration), and urethral perforation with fistula or perineal soft tissue infection.
次要结局
- Symptoms and quality of life using validated scale and questionnaires: ICIQ male LUTS (International Consultation on incontinence Questionnaire), USP (Urinary Symptom Profile) questionnaires and a PGII (Personnal Global impression of Improvement) scale
- US examination: Uroflowmetry (Qmax in ml/s, voided volume in ml) and post voiding residual volume using ultrasound bladder scan.
- Recurrence occurring between 3 months and 24 months after the ADSVF injection and defined as a urinary retention or a decrease in uroflowmetry and quality of life equal to baseline situation ± 20% in a patient asking for a relief after an initial period of improvement (compare to baseline values)
- Volume of spongiofibrosis using MRI in Sagittal view in T1 Fat Sat after Gadolinium injection (reconstruction to evaluate total volume in mm3 of spongiofibrosis).
研究者
INVESTIGATOR COORDINATOR
Scientific
Centre Hospitalier Regional De Marseille
研究点 (2)
Loading locations...
相似试验
已完成
2 期
The evaluation of the effectiveness, safety and tolerability of treatment, using a specialized prostate-specific membrane antigen (PSMA) labeled with Lutetium177, in patients with recurrent and/or metastatic adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trialAdenoid cystic carcinoma2023-504699-73-00Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy32
Enrolling By Invitation
不适用
"Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDNHypertensionNCT07273877Shanghai Golden Leaf MedTec Co. Ltd1,000
招募中
1 期
A Study of AK138D1 in Advanced Malignant TumorsNCT07281326Akeso200
招募中
1 期
A study to assess the safety, tolerability, uptake and efficacy of VMX-C001 in healthy volunteers.2023-507059-32-00VarmX B.V., VarmX B.V.48
招募中
2 期
Adjuvant therapy in stage IV colorectal cancer patients NED2024-518217-26-00IRCCS Ospedale Policlinico San Martino, IRCCS Ospedale Policlinico San Martino182