NCT01119820

Brief Summary

Analyze human skeletal muscle and learn more about the ability of adult muscle to produce myoblasts (young muscle cells).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

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

October 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

May 6, 2010

Last Update Submit

March 1, 2019

Conditions

Observe in Vitro Characteristics of Muscle TissueElective Obstetric or Gynecologic Surgery

Keywords

elective obstetric or gynecologic surgery

Outcome Measures

Primary Outcomes (1)

  • cell expansion

    The goal of this pilot study is to obtain small amounts of human skeletal muscle that would normally be discarded during gynecologic surgery and instead conserve this tissue for laboratory analysis.

    weekly

Study Arms (1)

Tissue Donation

EXPERIMENTAL

This study will involve females over 18 who are scheduled to undergo elective surgery. These patients will be screened for participation in this study, which will only involve the collection of discarded tissue.

Other: Tissue Donation

Interventions

Tissue DonationOTHER

Females over 18 who are scheduled to undergo elective surgery will have discarded tissue collected.

Tissue Donation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age: 18 years of age or older Female Patients who are already electing to undergo obstetric or gynecologic surgery (either vaginal or abdominal) for a preexisting condition.

You may not qualify if:

  • \- Active systemic or pelvic infections including HIV HBV HCV, STD, PID Patients with tumors, metastatic disease or treated with cytostatics Patients undergoing emergency surgical procedures Unconscious or mentally incapable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCI Women's Healthcare

Orange, California, 92868, United States

Location

MeSH Terms

Interventions

Tissue and Organ Procurement

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Felicia Lane, MD

    UCI Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 10, 2010

Study Start

October 1, 2008

Primary Completion

February 1, 2010

Study Completion

June 1, 2012

Last Updated

March 4, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)