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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Scar Diverticulum; Abnormal Vaginal Bleeding; Fertility Impairment
• Intervention / Treatment: Device: collagen fibrous scaffold; Procedure: Hysteroscopic localization of the diverticulum combined with laparoscopic diverticulectomy and repair

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuxiu Jiang, Ph.D & M.D; Phone Number: 2051 +86-0571-87061501; Email: jiangxiuxiu0418@zju.edu.cn
• Study Contact Backup: Name: Zhejiang Provincial Clinical Research Center for Gynecological Women's Hospital, Zhejiang University School of Medicine

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital, School of Medicine, Zhejiang University
      • Contact: Xiuxiu Jiang, Ph.D & M.D; Phone Number: 2051 +86-0571-87061501; Email: jiangxiuxiu0418@zju.edu.cn
      • Principal Investigator: Ning Wang, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: collagen fibrous scaffold; The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without implantable collagen fibrous scaffold .; Other Names: Scaffold
Active Comparator: Arm 2: Control Group; Identical hysteroscopic combined laparoscopic surgical repair of the CSD defect; no collagen fibrous scaffold is implanted.	Procedure: Hysteroscopic localization of the diverticulum combined with laparoscopic diverticulectomy and repair; The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without placement of implantable collagen fibrous scaffold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in cesarean scar niche volume (mL)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in abnormal vaginal bleeding	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	Include clinical pregnancy rate among participants attempting conception.	Baseline to 12 months
Reproductive outcome- ongoing pregnancy rate	Include ongoing pregnancy rate among participants attempting conception.	Baseline to 12 months
Reproductive outcome - early pregnancy loss rate	Include early pregnancy loss rate among participants attempting conception.	Baseline to 12 months
Reproductive outcome - cesarean scar pregnancy rate	Include cesarean scar pregnancy rate among participants attempting conception.	Baseline to 12 months
Incidence of adverse events	All device-related and procedure-related adverse events, graded by severity and causality.	Intraoperative through 12 months
Recurrence rate of cesarean scar diverticulum	Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution.	12 months

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University

Publications and helpful links

General Publications

• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 6, 2032

Study Registration Dates

• First Submitted: November 5, 2026
• First Submitted That Met QC Criteria: November 10, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 10, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Biomaterial; Cesarean Scar Diverticulum; Uterine Niche; Collagen Fibrous Scaffold; Abnormal Vaginal Bleeding; Reproductive Outcome; Prospective Multicenter Controlled Study
• Additional Relevant MeSH Terms: Biological Phenomena; Regeneration; Wound Healing
• Other Study ID Numbers: WHZ-JXX; 2025C02122 (Other Grant/Funding Number: the Zhejiang Province's 2025 'Pioneer Leading Swan + X' Science and Technology Program); 2024ZY01028 (Other Grant/Funding Number: the Zhejiang Provincial Central Leading Local Science and Technology Development Fund Project); ZDFY2023-4XPY101 (Other Grant/Funding Number: the 4+X Clinical Research of Women's Hospital, School of Medicine, Zhejiang University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No