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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xiuxiu Jiang, Ph.D & M.D
- 電話番号：2051 +86-0571-87061501
- メール：jiangxiuxiu0418@zju.edu.cn
研究連絡先のバックアップ
- 名前：Zhejiang Provincial Clinical Research Center for Gynecological Women's Hospital, Zhejiang University School of Medicine
研究場所
-
-
Zhejiang
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Hangzhou、Zhejiang、中国、310006
- Women's Hospital, School of Medicine, Zhejiang University
-
コンタクト：
- Xiuxiu Jiang, Ph.D & M.D
- 電話番号：2051 +86-0571-87061501
- メール：jiangxiuxiu0418@zju.edu.cn
-
主任研究者：
- Ning Wang, M.D
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 .
他の名前：
|
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in cesarean scar niche volume (mL)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in abnormal vaginal bleeding
時間枠：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
時間枠：Baseline to 12 months
|
Include clinical pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome- ongoing pregnancy rate
時間枠：Baseline to 12 months
|
Include ongoing pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - early pregnancy loss rate
時間枠：Baseline to 12 months
|
Include early pregnancy loss rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - cesarean scar pregnancy rate
時間枠：Baseline to 12 months
|
Include cesarean scar pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Incidence of adverse events
時間枠：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
時間枠：12 months
|
Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution. |
12 months
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- WHZ-JXX
- 2025C02122 (その他の助成金/資金番号：the Zhejiang Province's 2025 'Pioneer Leading Swan + X' Science and Technology Program)
- 2024ZY01028 (その他の助成金/資金番号：the Zhejiang Provincial Central Leading Local Science and Technology Development Fund Project)
- ZDFY2023-4XPY101 (その他の助成金/資金番号：the 4+X Clinical Research of Women's Hospital, School of Medicine, Zhejiang University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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