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NCT04415944 · ClinicalTrials.gov registry record · Phase 2

Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target

NCT04415944: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT04415944 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04415944, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Primary Outcome

The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.

Interventions

  • PROCEDURE Second look laparoscopy reassessment surgery (SLLRS)
  • DRUG HIPEC with Carboplatin
  • OTHER FACT-O Quality of Life Questionnaire

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2021-05-20
Est. Completion 2026-01-23
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT04415944 record still lists

NCT04415944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 3 interventions - of which Second look laparoscopy reassessment surgery (SLLRS) is the first listed.

NCT04415944 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04415944 about?

NCT04415944 is a clinical study titled "Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy". The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' heal...

What is the current status of trial NCT04415944?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2021-05-20. Estimated completion is 2026-01-23.

What interventions are being tested in trial NCT04415944?

The interventions under investigation include: Second look laparoscopy reassessment surgery (SLLRS) (PROCEDURE), HIPEC with Carboplatin (DRUG), FACT-O Quality of Life Questionnaire (OTHER).

Who is sponsoring clinical trial NCT04415944?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04415944's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT04415944, the US trial registry maintained by the National Library of Medicine. NCT04415944 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.