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NCT01198691 · ClinicalTrials.gov registry record · Phase 2

A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)

A Phase 2 study of Cesarean Section, sponsored by TriHealth.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target
1
Study location

NCT01198691 is a Phase 2 study of Cesarean Section that has completed, run by TriHealth. The registered enrollment target is 100 participants, below the 163-participant average among 14 other Cesarean Section trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01198691, a Phase 2 study of Cesarean Section, has completed, sponsored by TriHealth.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

Conditions Studied

Interventions

  • DEVICE Insorb absorbable staples
  • DEVICE Insorb

Study Locations (1)

Ohio

  • Good Samaritan Hospital - Cincinnati

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2010-07
Est. Completion 2011-05
Phase Phase 2

Sponsor

TriHealth

81 total trials

What the Registry Record Tells You About NCT01198691

The ClinicalTrials.gov registry entry for NCT01198691 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 14 other Cesarean Section trials with a reported enrollment target (39% lower). The listed sponsor is TriHealth, which has 81 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cesarean Section appearing as the primary indexed condition, and to 2 interventions - of which Insorb absorbable staples is the first listed.

NCT01198691 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT01198691 about?

NCT01198691 is a clinical study titled "A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)". The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

What is the current status of trial NCT01198691?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2010-07. Estimated completion is 2011-05.

What conditions does trial NCT01198691 study?

This clinical trial studies the following conditions: Cesarean Section.

What interventions are being tested in trial NCT01198691?

The interventions under investigation include: Insorb absorbable staples (DEVICE), Insorb (DEVICE).

Who is sponsoring clinical trial NCT01198691?

This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01198691 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.