A Prospective, Multicenter, Controlled Clinical Study of Collagen Fibrous Scaffold for the Treatment of Cesarean Scar Diverticulum
NCT07930689, Not applicable, Not yet recruiting, Women's Hospital School Of Medicine Zhejiang University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Prospective, Multicenter, Controlled Clinical Study of Collagen Fibrous Scaffold for the Treatment of Cesarean Scar Diverticulum | ClinicalTrials.gov |
| NCT number | NCT07930689 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Women's Hospital School Of Medicine Zhejiang University | ClinicalTrials.gov |
| Conditions | Cesarean Scar Diverticulum, Abnormal Vaginal Bleeding, Fertility Impairment | ClinicalTrials.gov |
| Interventions | collagen fibrous scaffold, Hysteroscopic localization of the diverticulum combined with laparoscopic diverticulectomy and repair | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in cesarean scar niche volume (mL) | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in abnormal vaginal bleeding | 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. | ClinicalTrials.gov |
| Secondary | Reproductive outcome-clinical pregnancy rate | Baseline to 12 months | Include clinical pregnancy rate among participants attempting conception. | ClinicalTrials.gov |
| Secondary | Reproductive outcome- ongoing pregnancy rate | Baseline to 12 months | Include ongoing pregnancy rate among participants attempting conception. | ClinicalTrials.gov |
| Secondary | Reproductive outcome - early pregnancy loss rate | Baseline to 12 months | Include early pregnancy loss rate among participants attempting conception. | ClinicalTrials.gov |
| Secondary | Reproductive outcome - cesarean scar pregnancy rate | Baseline to 12 months | Include cesarean scar pregnancy rate among participants attempting conception. | ClinicalTrials.gov |
| Secondary | Incidence of adverse events | Intraoperative through 12 months | All device-related and procedure-related adverse events, graded by severity and causality. | ClinicalTrials.gov |
| Secondary | Recurrence rate of cesarean scar diverticulum | 12 months | Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.