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NCT01051856 · ClinicalTrials.gov registry record · Phase 4

TissueLink Versus SEAMGUARD After Distal Pancreatectomy

A Phase 4 study, sponsored by Mayo Clinic.

Terminated
Registry status
Phase 4
Development phase
68
Enrollment target

NCT01051856: Clinical Trial Phase 4 study, sponsored by Mayo Clinic.

NCT01051856 is a Phase 4 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 68 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01051856, a Phase 4 study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
Phase 4
Development phase
68 participants
Enrollment target

Study Summary

The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.

Primary Outcome

Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.

Interventions

  • DEVICE SEAMGUARD with bioabsorbable staple
  • PROCEDURE TissueLink with radiofrequency ablation

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2009-12
Est. Completion 2015-03
Phase Phase 4
Mayo Clinic

2,844 total trials

Why NCT01051856 stopped before completion

NCT01051856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which SEAMGUARD with bioabsorbable staple is the first listed.

NCT01051856 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01051856 about?

NCT01051856 is a clinical study titled "TissueLink Versus SEAMGUARD After Distal Pancreatectomy". The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices...

What is the current status of trial NCT01051856?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 68 participants. The study started on 2009-12. Estimated completion is 2015-03.

What interventions are being tested in trial NCT01051856?

The interventions under investigation include: SEAMGUARD with bioabsorbable staple (DEVICE), TissueLink with radiofrequency ablation (PROCEDURE).

Who is sponsoring clinical trial NCT01051856?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01051856's enrollment target sits among peer trials

68 1076th of 2000 higher than 918 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01051856, the US trial registry maintained by the National Library of Medicine. NCT01051856 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.