NCT03642054

Brief Summary

This study will assess advanced biomarkers in patients with and without vaginal prolapse. Assessments will be directed at vaginal fibroblasts and adipose derived stem cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2020

Completed
Last Updated

September 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

August 20, 2018

Last Update Submit

September 20, 2021

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Advanced biomarker assessments will include messenger RNA sequencing.

    RNA-Seq will determine if there are differences in mRNA or exon expression between cells from prolapse and normal patients, with focus on genes involved in connective tissue metabolism (e.g., collagens, MMPs, TIMPs, myofibroblast markers).

    one year

Secondary Outcomes (1)

  • 2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse.

    1.5 years

Study Arms (2)

Pelvic Organ Prolapse

Patients having vaginal hysterectomy who demonstrate grade III-IV uterovaginal prolapse.

Non Pelvic Organ Prolapse

Patients having vaginal hysterectomy who do not demonstrate uterovaginal prolapse.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsUndergoing a vaginal hysterectomy for either a pelvic organ prolapse or a non-prolapse benign condition.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

6 patients with pelvic organ prolapse and 6 patients without pelvic organ prolapse.

You may qualify if:

  • Patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse
  • at least 18 years old
  • Mayo Clinic patient

You may not qualify if:

  • °Patients who have a history of a recognized classic connective tissue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Adipose Derived Stem Cells Fibroblast Stem Cells

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Johnny Yi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 22, 2018

Study Start

June 29, 2018

Primary Completion

May 18, 2020

Study Completion

May 18, 2020

Last Updated

September 24, 2021

Record last verified: 2021-08

Locations

US(1)