Restorelle Direct Fix Anterior & Posterior (A&P) for Female Pelvic Organ

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00597935` - Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT00597935 - Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT01378065
Study type	Observational
Source	Coloplast A/S
Contact
Status	Completed
Phase
Start date	June 2011
Completion date	September 2013

Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study — (A&P)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms