A Prospective, Multicenter, Controlled Clinical Study of Collagen Fibrous Scaffold for the Treatment of Cesarean Scar Diverticulum (CSD-SCAFFOLD)
Cesarean scar diverticulum (CSD, uterine niche) is a common long-term complication of cesarean delivery, frequently presenting with abnormal vaginal bleeding (postmenstrual spotting, prolonged menses), pelvic pain, and adverse reproductive outcomes. Current surgical repair yields variable niche shrinkage and inconsistent symptom and fertility improvement. This prospective, multicenter, controlled study aims to evaluate the efficacy and safety of collagen fibrous scaffold implantation versus conventional repair alone. Eligible symptomatic women will be enrolled from multiple tertiary obstetrics and gynecology centers. The primary outcome is change in CSD niche volume measured by transvaginal three-dimensional ultrasound. Secondary outcomes include improvement of abnormal vaginal bleeding and reproductive outcomes. Participants will be followed at 1, 3, 6, and 12 months postoperatively.
Visão geral do estudo
Status
Descrição detalhada
This is a prospective, multicenter, parallel controlled interventional study in symptomatic women with cesarean scar diverticulum. Subjects meeting the inclusion criteria will be allocated to the intervention group (collagen fibrous scaffold implantation) or the control group (standard surgical repair without scaffold).
Baseline assessments include transvaginal 3D ultrasound for niche volume measurement, menstrual symptom diary, pelvic pain evaluation, reproductive history, pelvic imaging, and routine laboratory tests. The index repair surgery (hysteroscopic combined laparoscopic) is performed per standardized protocol by experienced gynecologic surgeons. In the intervention group, the collagen fibrous scaffold is placed at the CSD to support tissue regeneration and scar remodeling. The control group receives identical surgical repair without scaffold implantation.
Follow-up visits are scheduled at 1, 3, 6, and 12 months after surgery. At each visit, adverse events, vaginal bleeding pattern, menstrual duration, and pelvic discomfort are recorded. Transvaginal 3D ultrasound is performed to quantify niche volume. Reproductive data including spontaneous conception, clinical pregnancy, pregnancy continuation, and pregnancy complications are collected up to 12 months. Safety endpoints include intraoperative hemorrhage, visceral injury, surgical site infection, scaffold-related reactions, pelvic adhesion, and persistent pain. All adverse events are graded for severity and assessed for relatedness to the study device or procedure.
Primary analysis compares between-group difference in niche volume change from baseline to 6 months. Secondary analyses compare abnormal vaginal bleeding parameters and reproductive outcomes. Safety profiles will be summarized. Analyses will be conducted on intention-to-treat and per-protocol populations.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Xiuxiu Jiang, Ph.D & M.D
- Número de telefone: 2051 +86-0571-87061501
- E-mail: jiangxiuxiu0418@zju.edu.cn
Estude backup de contato
- Nome: Zhejiang Provincial Clinical Research Center for Gynecological Women's Hospital, Zhejiang University School of Medicine
Locais de estudo
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310006
- Women's Hospital, School of Medicine, Zhejiang University
-
Contato:
- Xiuxiu Jiang, Ph.D & M.D
- Número de telefone: 2051 +86-0571-87061501
- E-mail: jiangxiuxiu0418@zju.edu.cn
-
Investigador principal:
- Ning Wang, M.D
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- At least one prior cesarean delivery
- CSD confirmed by transvaginal 3D ultrasound with measurable niche volume
- Symptomatic CSD: abnormal vaginal bleeding (prolonged menstruation, postmenstrual spotting, intermenstrual bleeding) attributed to the niche
- Candidate for surgical CSD repair and willing to complete scheduled follow-up
- Signed written informed consent
Exclusion Criteria:
- Current pregnancy or unwillingness to use effective contraception for the first 6 months postoperatively
- Coexisting uterine lesions requiring separate surgical intervention (submucous fibroids, large endometrial polyps, adenomyosis with dominant lesion)
- Active pelvic inflammatory disease or untreated genital tract infection
- Known allergy or hypersensitivity to collagen-derived biomaterials
- Severe systemic disease or coagulopathy that contraindicates pelvic surgery
- Suspected or confirmed gynecologic malignancy
- Inability or unwillingness to complete required follow-up assessments
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm 1: Intervention Group
Collagen fibrous scaffold is implanted at the site of the cesarean scar diverticulum under 3D ultrasound guidance, without hysteroscopic or laparoscopic surgery. |
The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without implantable collagen fibrous scaffold .
Outros nomes:
|
|
Comparador Ativo: Arm 2: Control Group
Identical hysteroscopic combined laparoscopic surgical repair of the CSD defect; no collagen fibrous scaffold is implanted. |
The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without placement of implantable collagen fibrous scaffold. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in cesarean scar niche volume (mL)
Prazo: Baseline, 3 months
|
Cesarean scar niche volume will be assessed by three-dimensional transvaginal ultrasound and calculated by the ellipsoid formula （V = 0.523 × length × width × depth）at baseline and 3 months after intervention. |
Baseline, 3 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in abnormal vaginal bleeding
Prazo: Baseline, 3, 6, 12 months
|
Assessed by menstrual diary, including total menstrual bleeding days, days of postmenstrual spotting, and intermenstrual bleeding episodes per menstrual cycle. |
Baseline, 3, 6, 12 months
|
|
Reproductive outcome-clinical pregnancy rate
Prazo: Baseline to 12 months
|
Include clinical pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome- ongoing pregnancy rate
Prazo: Baseline to 12 months
|
Include ongoing pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - early pregnancy loss rate
Prazo: Baseline to 12 months
|
Include early pregnancy loss rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - cesarean scar pregnancy rate
Prazo: Baseline to 12 months
|
Include cesarean scar pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Incidence of adverse events
Prazo: Intraoperative through 12 months
|
All device-related and procedure-related adverse events, graded by severity and causality. |
Intraoperative through 12 months
|
|
Recurrence rate of cesarean scar diverticulum
Prazo: 12 months
|
Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution. |
12 months
|
Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- Tosi A, Haas C, Herzog F, Gilmozzi A, Berninghausen O, Ungewickell C, Gerhold CB, Lakomek K, Aebersold R, Beckmann R, Hopfner KP. Structure and subunit topology of the INO80 chromatin remodeler and its nucleosome complex. Cell. 2013 Sep 12;154(6):1207-19. doi: 10.1016/j.cell.2013.08.016.
- Perkins JR, Parker CE, Tomer KB. Nanoscale separations combined with electrospray ionization mass spectrometry: Sulfonamide determination. J Am Soc Mass Spectrom. 1992 Feb;3(2):139-49. doi: 10.1016/1044-0305(92)87047-3.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WHZ-JXX
- 2025C02122 (Número de outro subsídio/financiamento: the Zhejiang Province's 2025 'Pioneer Leading Swan + X' Science and Technology Program)
- 2024ZY01028 (Número de outro subsídio/financiamento: the Zhejiang Provincial Central Leading Local Science and Technology Development Fund Project)
- ZDFY2023-4XPY101 (Número de outro subsídio/financiamento: the 4+X Clinical Research of Women's Hospital, School of Medicine, Zhejiang University)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .