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NCT00599261 · ClinicalTrials.gov registry record · Phase 4

MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study

A Phase 4 study of Infection, sponsored by Dhanunjaya Lakkireddy, MD, FACC.

Completed
Registry status
Phase 4
Development phase
265
Enrollment target
1
Study location

NCT00599261: Completed Phase 4 study of Infection, sponsored by Dhanunjaya Lakkireddy, MD, FACC.

NCT00599261 is a Phase 4 study of Infection that has completed, run by Dhanunjaya Lakkireddy, MD, FACC. The registered enrollment target is 265 participants, below the 720-participant average among 41 other Infection trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00599261, a Phase 4 study of Infection, has completed, sponsored by Dhanunjaya Lakkireddy, MD, FACC.

COMPLETED
Registry status
Phase 4
Development phase
265 participants
Enrollment target
1
Study location

Study Summary

To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

Conditions Studied

Interventions

  • PROCEDURE ICD/pacemaker pocket revision

Study Locations (1)

Kansas

  • University of Kansas Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 265 participants
Start Date 2008-01
Est. Completion 2012-12
Phase Phase 4
Dhanunjaya Lakkireddy, MD, FACC

7 total trials

What the finished NCT00599261 record still lists

NCT00599261 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, below the 720-participant average among 41 other Infection trials with a reported enrollment target (63% lower).

The record links to 1 condition, with Infection appearing as the primary indexed condition, and to 1 intervention - of which ICD/pacemaker pocket revision is the first listed.

NCT00599261 reports a single indexed study location in Kansas.

Frequently Asked Questions

What is clinical trial NCT00599261 about?

NCT00599261 is a clinical study titled "MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study". To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

What is the current status of trial NCT00599261?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 265 participants. The study started on 2008-01. Estimated completion is 2012-12.

What conditions does trial NCT00599261 study?

This clinical trial studies the following conditions: Infection.

What interventions are being tested in trial NCT00599261?

The interventions under investigation include: ICD/pacemaker pocket revision (PROCEDURE).

Who is sponsoring clinical trial NCT00599261?

This trial is sponsored by Dhanunjaya Lakkireddy, MD, FACC, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00599261 being conducted?

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

Similar trials for Infection

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00599261's enrollment target sits among peer trials

265 20th of 41 higher than 22 of 41 other Infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00599261, the US trial registry maintained by the National Library of Medicine. NCT00599261 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.