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More info
You can access this
clinical trial
if you have
Gastrostomy, Methods
and you are
between 18 and 85
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

Endoscopic placement of a percutaneous gastrostomy tube is a safe, efficient and well standardized technique. Two variants of this maneuver - the pull and the push techniques - are widespread worldwide. More recently different techniques, that allow the direct insertion of a gastrostomy tube has been described. The common characteristic shared by all these technique is the fact that the gastrostomy tube is inserted directly into the stomach (without passing through the pharynx), after the gastric and abdominal wall have been securely fasten together (gastropexy). Advantage of direct techniques are the followings: 1. the tube can placed also in the case of an oesophageal stenosis 2. studies suggest that the peristomal wound infection are less frequent using direct techniques 3. in some variants of these techniques, a balloon type gastrostomy tube or a button can be placed also in the case of first positioning. Both the balloon type tube and the button are easy to be changed also at the bed-side. Drawbacks of the direct techniques are: 1. these technique are easy, but a little more cumbersome than classic push or pull maneuvers 2. operators are often not familiar with direct insertion 3. kits suited for direct insertion are generally more costly than available kits for push or pull placement of gastrostomy tube. The kit manufactured by the Kimberly-Clark (MIC Introducer kit) allows direct insertion of a balloon type gastrostomy tube or of a button and it is interesting, because it makes simple to perform the gastropexy. The study aim is to confirm that the use of the Kit Introducer MIC, may allow safe placement of a gastrostomy tube and may reduce the incidence of peristomal wound infection. Furthermore if a balloon type gastrostomy tube or a button are positioned, they may be changed at the bed-side, without referral of the patient to the endoscopic unit or to an other sanitary facility.

Provided treatments

  • Device: A 20 Fr gastrostomy tube, placed using push/pull techniques.
  • Device: A 20 Fr balloon type tube, placed after gastropexy.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01463540. The sponsor of the trial is Lorenzo Camellini and it is looking for 206 volunteers for the current phase.
Official trial title:
A Multicentric, Randomised Clinical Trial Comparing Short and Long Time Outcome of Gastrostomy Tube Placed After Gastropexy, Versus Gastrostomy Tube Placed Using the Traditional Push/Pull Techniques