رادار التجارب AI | ||
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حالة التجربة السريرية NCT07255508 (SQUID-PAE) لـ Benign Prostate Hypertrophy(BPH) هي لم يبدأ التجنيد بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
مستشفيات باريس العامةEfficacy of Prostatic Arteries Embolization Using SQUIDPERI (SQUID-PAE)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07255508 (SQUID-PAE) هي دراسة رصدية لـBenign Prostate Hypertrophy(BPH) وهي لم يبدأ التجنيد بعد. من المقرر أن يبدأ التسجيل في ١٠ جمادى الأولى ١٤٤٧ هـ لتجنيد ١٠٠ مشاركًا. يقودها مستشفيات باريس العامة، ومن المتوقع اكتمالها بحلول ٢ جمادى الآخرة ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٠ جمادى الآخرة ١٤٤٧ هـ.
الملخص
Prostatic Artery Embolization (PAE) is a recognized mini-invasive treatment of bothersome Lower Urinary Tract Symptoms (LUTS) related to Benign Prostatic Hyperplasia (BPH). Particle embolics are used almost exclusively for embolization, with wide variation in the type and size of particles showing similar performance and safety results. Even if its durability relies on multiple risk factors, LUTS recurrence-free survival probability decreases with years. It is demonstrated that recanalization of the native prostatic artery is found in 66% of patients experiencing LUTS recurrence. Artery recanalization after several months has been reported in embolization with microparticles. The investigators addressed this issue using the liquid embolic agent SQUIDPERI in a prospective cohort of patients undergoing rePAE and showed a good clinical success rate (76.7%) at 3 months. Since then, the investigators perform initial PAE using SQUIDPERI with good results.
The aim of SQUID-PAE study is to assess the efficacy of PAE using SQUIDPERI in an initial PAE setting in a multicenter prospective study.
العنوان الرسمي
Efficacy of Prostatic Arteries Embolization Using SQUIDPERI
الحالات الطبية
Benign Prostate Hypertrophy(BPH)معرّفات دراسة أخرى
- SQUID-PAE
- APHP250088
- 2025-A00926-43 (معرف آخر) (ANSM (French National Agency for the Safety of Medicines and Health Products))
NCT معرّف
تاريخ البدء (فعلي)
2025-11
آخر تحديث مُنشور
2025-12-01
تاريخ الاكتمال (المقدر)
2027-11
عدد المشاركين المخطط لهم
١٠٠
نوع الدراسة
رصدية
الحالة
لم يبدأ التجنيد بعد
الكلمات الرئيسية
Prostatic Artery Embolization
PAE
SQUIDPERI
Liquid Embolic Agent
PAE
SQUIDPERI
Liquid Embolic Agent
مجموعات/التدخلات
| مجموعة المشاركين/مجموعة | تَدَخُّل/علاج |
|---|---|
Study group Prostatic Artery Embolization | Liquid Embolic Agent Prostatic Artery Embolization using a non-adhesive liquid embolic agent composed of an EVOH (ethylene-vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), with micronized tantalum powder suspended within it |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Clinical success at 3 months | Rate of clinical success defined as an IPSS \<18 at follow-up with a decrease from baseline \> 25% AND a quality of life (QoL, last question of IPSS questionnaire) \< 4 at follow-up with a decrease from baseline ≥ 1. | Baseline and 3 months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Immediate technical success | Rate of immediate technical success. Immediate technical success is defined as an embolization of both lobes of the prostate using SQUID PERI. | Embolization procedure (baseline) |
Clinical success at 6 months | Rate of clinical success defined as an IPSS \<18 at follow-up with a decrease from baseline \> 25% AND a quality of life (QoL, last question of IPSS questionnaire) \< 4 at follow-up with a decrease from baseline ≥ 1. | Baseline and 6 months |
Clinical success at 9 months | Rate of clinical success defined as an IPSS \<18 at follow-up with a decrease from baseline \> 25% AND a quality of life (QoL, last question of IPSS questionnaire) \< 4 at follow-up with a decrease from baseline ≥ 1. | Baseline and 9 months |
Clinical success at 12 months | Rate of clinical success defined as an IPSS \<18 at follow-up with a decrease from baseline \> 25% AND a quality of life (QoL, last question of IPSS questionnaire) \< 4 at follow-up with a decrease from baseline ≥ 1. | Baseline and 12 months |
IPSS at 3 months | Change in IPSS score and subscores compared to baseline. | Baseline and 3 months |
IPSS at 6 months | Change in IPSS score and subscores compared to baseline. | Baseline and 6 months |
IPSS at 9 months | Change in IPSS score and subscores compared to baseline. | Baseline and 9 months |
IPSS at 12 months | Change in IPSS score and subscores compared to baseline. | Baseline and 12 months |
QoL at 3 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 3 months |
QoL at 6 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 6 months |
QoL at 9 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 9 months |
QoL at 12 months | Change in QoL score (last question of IPSS questionnaire) compared to baseline. | Baseline and 12 months |
IIEF-15 at 3 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 3 months |
IIEF-15 at 6 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 6 months |
IIEF-15 at 9 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 9 months |
IIEF-15 at 12 months | Change in IIEF-15 score and subscores compared to baseline. | Baseline and 12 months |
Adverse events and serious adverse events | Number of adverse events and serious adverse events. | Up to 12 months |
Benign prostatic hyperplasia medication at baseline | Number of benign prostatic hyperplasia medication. | Baseline |
Benign prostatic hyperplasia medication at 3 months | Number of benign prostatic hyperplasia medication. | 3 months |
Re-intervention for benign prostatic hyperplasia at 12 months | Rate of re-intervention for benign prostatic hyperplasia (surgery, prostatic artery embolization). | Up to 12 months |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
ذكر
- Age ≥18 years
- Patient scheduled for a PAE using SquidPERI as part of routine care
- Patient informed who signed the informed consent form
- French social security affiliation
- Good understanding of the French language
- Patient unwilling or unlikely to comply with FU schedule
- Known severe allergy to iodine
- Known severe hepatic impairment
- Vulnerable patient populations (such as patient under guardianship, curatorship, deprived of liberty)
- Patient that already had a PAE
- Patient on AME (state medical aid)
- Participation in any interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
مستشفيات باريس العامة961 تجارب سريرية نشطة للاستكشافBalt Internationalجهة اتصال مركزية للدراسة
جهة اتصال: Touria EL AAMRI, Project manager, +33 (0)1 40 27 18 48, [email protected]
4 مواقع الدراسة في 1 بلدان
Hôpital Timone (Radiologie adultes et neuroradiologie), Marseille, 13385, France
Vincent VIDAL, جهة اتصال, +33 (0) 4 13 42 90 60, [email protected]
Hôpital Arnaud de Villeneuve (Service Imagerie diagnostique et interventionnelle), Montpellier, 34295, France
Hélène KOVACSIK, جهة اتصال, +33 (0) 4 67 33 60 00, [email protected]
Hôpital Européen Georges Pompidou - AP-HP (Radiologie Interventionnelle vasculaire et oncologique), Paris, 75015, France
Marc SAPOVAL, جهة اتصال, +33 (0) 1 56 09 37 40, [email protected]
Institut Cardiovasculaire de Strasbourg (ICS) - Clinique Rhena (Radiologie interventionnelle vasculaire et oncologique), Strasbourg, 67000, France
Gilles GOYAULT, جهة اتصال, +33 (0) 3 90 67 39 91, [email protected]