An interventional study of collagen fibrous scaffold and Hysteroscopic localization of the diverticulum combined with laparoscopic diverticulectomy and repair in Cesarean Scar Diverticulum, Abnormal Vaginal Bleeding and Fertility Impairment, sponsored by Women's Hospital School Of Medicine Zhejiang University. Not yet recruiting at 1 site in China. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Treatment
Among 41 studies in Cicatrix with a site in China — 9 open to participants now, 9 under way, none of them phase 3. Cicatrix · China.
Among the 41 studies in Cicatrix with a site in China, this one is the 12th largest by planned enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2026, is one of 22 with no phase, and was the 41st registered.
612 studies on the registry are indexed under Cicatrix; 115 are open to participants now.
Browse Cicatrix studies →9 of the 41 studies in Cicatrix with a site in China are open now. Recruiting first, the newest first:
Peking University Third Hospital · Sites in China
Ages 20–50
Mabwell (Shanghai) Bioscience Co., Ltd. · Sites in China
Ages 18+
Women's Hospital School Of Medicine Zhejiang University · Sites in China
Ages 18+ · Women only
LIAO Peng · Sites in China
Ages 3–6
First Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages up to 80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 69 Cicatrix studies recruiting now, 34 (49%) set no upper age limit and 31 (45%) stop at 75 or younger; 11 take children under 18; 16 take healthy volunteers.
This study: 20 Years to 45 Years · female · healthy volunteers too.
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41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 2
First in 2011; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 80 is above the median of 40 across 513 interventional studies indexed under Cicatrix.
Median enrollment 50 across the 33 interventional studies, 119 across the 8 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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3 of 41 have an industry lead sponsor. The 10 most frequent:
Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 80 studies on the registry; 50 are open to participants now.
Women's Hospital School Of Medicine Zhejiang University has 2 studies filed under Cicatrix — fewer than ten, so there is no comparison to draw.
4 of the studies in Cicatrix with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07576608Mabwell (Shanghai) Bioscience Co., Ltd.A Phase II Study of 9MW3811 in Patients With Pathological Scar | 2026-12 |
| NCT07608094Women's Hospital School Of Medicine Zhejiang UniversityThe Treatment Outcomes of Cesarean Scar Pregnancy | 2026-12-31 |
| NCT07620769CLASSYS Inc.Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars | 2027-03 |
| NCT07849010Peking University Third HospitalDisposable Noninvasive Skin Closure for Promoting Postoperative Wound Healing and Preventing Surgical Skin Scarring | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 41 studies in Cicatrix with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 implantable collagen fibrous scaffold .
Also known as: Scaffold
The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without placement of implantable collagen fibrous scaffold.
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.
Time frame: Baseline, 3 months
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.
Time frame: Baseline, 3, 6, 12 months
Reproductive outcome-clinical pregnancy rate
Include clinical pregnancy rate among participants attempting conception.
Time frame: Baseline to 12 months
Reproductive outcome- ongoing pregnancy rate
Include ongoing pregnancy rate among participants attempting conception.
Time frame: Baseline to 12 months
Reproductive outcome - early pregnancy loss rate
Include early pregnancy loss rate among participants attempting conception.
Time frame: Baseline to 12 months
Reproductive outcome - cesarean scar pregnancy rate
Include cesarean scar pregnancy rate among participants attempting conception.
Time frame: Baseline to 12 months
Incidence of adverse events
All device-related and procedure-related adverse events, graded by severity and causality.
Time frame: 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.
Time frame: 12 months
Plan to share: No
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 173 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 36 months is above that.
Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Women's Hospital School Of Medicine Zhejiang University