CLINICAL TRIAL

X-Tack for Fistula

Recruiting · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether a new device called X-tack is as effective as the current device called Overstitch.

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About the trial for Fistula

Eligible Conditions
Polyps of Colon · Colonic Polyps · Fistula

Treatment Groups

This trial involves 2 different treatments. X-Tack is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
X-Tack
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Overstitch
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The age of 18 years. show original
The patient has a gastrointestinal hole that needs to be sewn up. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At time of endoscopy and phone calls 48-72 hours and 1 week after procedure
Screening: ~3 weeks
Treatment: Varies
Reporting: At time of endoscopy and phone calls 48-72 hours and 1 week after procedure
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At time of endoscopy and phone calls 48-72 hours and 1 week after procedure.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether X-Tack will improve 1 primary outcome and 4 secondary outcomes in patients with Fistula. Measurement will happen over the course of At time of endoscopy and phone calls 48-72 hours and 1 week after procedure.

Perforation
AT TIME OF ENDOSCOPY AND PHONE CALLS 48-72 HOURS AND 1 WEEK AFTER PROCEDURE
Perforation at closure site
AT TIME OF ENDOSCOPY AND PHONE CALLS 48-72 HOURS AND 1 WEEK AFTER PROCEDURE
Incomplete closure
AT TIME OF ENDOSCOPY
Either crossover to the other study group per endoscopist's discretion, or the need for additional modalities to close the defect such as endoscopic clips
AT TIME OF ENDOSCOPY
Time to closure
AT TIME OF ENDOSCOPY
The time required to close the defect using the device
AT TIME OF ENDOSCOPY
Bleeding
AT TIME OF ENDOSCOPY AND PHONE CALLS 48-72 HOURS AND 1 WEEK AFTER PROCEDURE
Bleeding from closure site
AT TIME OF ENDOSCOPY AND PHONE CALLS 48-72 HOURS AND 1 WEEK AFTER PROCEDURE
Infection
AT TIME OF ENDOSCOPY AND PHONE CALLS 48-72 HOURS AND 1 WEEK AFTER PROCEDURE
Infection at closure site
AT TIME OF ENDOSCOPY AND PHONE CALLS 48-72 HOURS AND 1 WEEK AFTER PROCEDURE

Who is running the study

Principal Investigator
A. K.
Prof. Anand Kumar, Associate Professor of Medicine
Thomas Jefferson University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of fistula?

An abdominal swelling often has been thought to be due to fistula because the symptoms usually involve the ileum. However, some patients can only complain of abdominal bloating, a mild abdominal pain without the presence of a fistula. It is suggested that a computed tomography scan should be done when suspicion of a fistula is high and that we try to do a surgery first when the suspicion of a fistula is really not high.

Anonymous Patient Answer

What causes fistula?

There are many causes of fistula, including injury, infection, tumours in the gastrointestinal tract and disease of the bladder. To clarify the cause of a fistula, various investigations are needed.\n

Anonymous Patient Answer

How many people get fistula a year in the United States?

The number of U.S. patients with fistula is low, and a low incidence is also noted for a variety of disorders. Further studies are necessary but are not feasible at the present time.

Anonymous Patient Answer

What are common treatments for fistula?

Many fistulas can usually be managed conservatively, but occasionally, surgery is needed to treat or close a fistula. Although a number of fistulas can be treated conservatively, any fistula that is suspected to be either complicated or refractory to the conservative management is best managed by surgery.

Anonymous Patient Answer

Can fistula be cured?

When the fistulae are plugged with bone and collagen and no active infection is present it is highly unlikely that the fistula will heal spontaneously. However, fistula closure in individuals with osteomyelitis may not be necessary.

Anonymous Patient Answer

What is fistula?

A fistula is a pathological opening (tear) between two normally separate body spaces. In gastroenterology, benign perforations tend to heal without complications, while malignant perforations (tears in the stomach and the bowel) may eventually lead to sepsis. Thus malignant gastric and colorectal perforations tend to require surgical intervention.\n

Anonymous Patient Answer

Who should consider clinical trials for fistula?

Patients with a known high-risk fistula are the population with the highest probability of achieving an adequate primary effect with clinical trials. On the other hand, patients with lower risk of an adequate primary effect are candidates for clinical trials if they do not meet the requirements of high risk factors.

Anonymous Patient Answer

What does x-tack usually treat?

Patients often referred to X-tack will have at least 1 of the indications in the common list of "in-vitro or in-vivo preparations and is not the most common cause for a referral to X-tack" in our facility. More importantly, the x-tack has minimal adverse effects and is the last line of treatment in most cases, which should not be overlooked. X-tack may be considered if patients who have a common list of indications have no evidence of another condition that explains their symptoms.

Anonymous Patient Answer

What is the average age someone gets fistula?

Most fistulas in the US are < 75 years old. This cohort of patients typically suffers from more extensive disease and typically requires more complex surgical procedures. The rate of fistula development is expected to increase with aging and with comorbidity.

Anonymous Patient Answer

How serious can fistula be?

Fistulas can have debilitating effects because of the pain, and they increase morbidity, mortality, surgical time and cost after surgery. Therefore, surgeons routinely treat fistulas.

Anonymous Patient Answer

Is x-tack typically used in combination with any other treatments?

Although X-tack is effective, it is often used in combination with [antibiotics and other herbal medicines], which can be beneficial. X-tack can also be used alone. Power presents several clinical trials options that may help people overcome their challenges.\n

Anonymous Patient Answer

What is the latest research for fistula?

The recent advancements of fistula surgery methods allow new techniques to be developed. The most recent methods are fistula management by endo-submucosal tunnel, fistula management by a new approach using buccal mucosa and subcutaneous flap, fistula resection with subcutaneous flaps, and fistula management by endoscopic incision and closure. Currently, fistulae can be treated by many techniques; however, the outcome depends on many factors, such as type, location, and number of fistulae.

Anonymous Patient Answer
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