An interventional study of NeoPatch in Tendinopathy, Tendon Tear and Tendon Injuries, sponsored by CryoLife, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by CryoLife, Inc. · Not applicable, Interventional, and Prevention
Among 99 studies in Tendinopathy with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Tendinopathy · United States.
Among the 99 studies in Tendinopathy with a site in United States, this one is the 76th largest by enrollment of the 89 interventional ones that give a count, is one of 10 that started in 2017, is one of 49 with no phase, and was the 45th registered.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
Browse Tendinopathy studies →15 of the 99 studies in Tendinopathy with a site in United States are open now. Recruiting first, the newest first:
Weill Medical College of Cornell University · Sites in United States
Joint & Vascular Institute · Sites in United States
The University of Texas Medical Branch, Galveston · Sites in United States
University of Utah · Sites in United States
Brigham and Women's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 47 Tendinopathy studies recruiting now, 16 (34%) set no upper age limit and 24 (51%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
99 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 12 · Phase 3 8 · Phase 4 15
First in 2002; this study’s year is marked. 10 started in 2017.
This study's enrollment of 7 is below the median of 48 across 332 interventional studies indexed under Tendinopathy.
Median enrollment 40 across the 89 interventional studies, 66 across the 10 observational. Of the 68 that completed or were terminated, 25 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 99 have an industry lead sponsor. The 10 most frequent:
CryoLife, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
CryoLife, Inc. has 1 study filed under Tendinopathy — fewer than ten, so there is no comparison to draw.
8 of the studies in Tendinopathy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06160427Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Connective Tissue Matrix for Rotator Cuff Tendinopathy | 2027-01-15 |
| NCT06095050Brigham and Women's HospitalEmbolization Treatment of Chronic Refractory Shoulder Tendinopathy | 2027-01-16 |
| NCT07642583Brooke Army Medical CenterDry Needling and Exercise for Mid-portion Achilles Tendinopathy | 2027-03-30 |
| NCT07553273The University of Texas Medical Branch, GalvestonVibratory Anesthesia on Pain Following Corticosteroid Injections | 2027-04 |
| NCT02600910The University of Texas Medical Branch, GalvestonNatural History of Shoulder Pathology in Manual Wheelchair Users | 2027-06 |
Among the 99 studies in Tendinopathy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring surgical revision. NeoPatch is a tissue covering derived from terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates for this study are patients presenting with chronic tendon pain that are being evaluated for primary tendon revision surgery following failure of standard of care or immediate need for surgery, as determined by the investigator. Consented patients will receive NeoPatch as an adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon immediately prior to closure. The study will be divided into two phases: Screening and Follow-up. The study will include prospective patient evaluations at scheduled clinic visits and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history, medications, self-reported pain, tendon status, and adverse events will be collected on all patients consented and enrolled into the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Intention to schedule surgical revision.
≥ 18 years.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NeoPatch
Other: NeoPatch
NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time frame: Up to 3 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time frame: Up to 9 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time frame: Up to 15 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time frame: Up to 52 weeks, post-op
Change in quantitative ultrasound assessment of post-operative adhesions
Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
Time frame: Through study completion, an average of 1 year
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time frame: Up to 3 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time frame: Up to 9 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time frame: Up to 15 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time frame: Up to 52 weeks, post-op
VAS Average Pain Score
Average self-reported pain experienced on average
Time frame: Up to 1 year, post-op
VAS Current Pain Score
Average self-reported pain experienced at time of assessment (current)
Time frame: Up to 1 year, post-op
Change in VAS Average Pain Score
Average change in self-reported average pain from baseline (screening) to last follow-up visit.
Time frame: Through study completion, an average of 1 year
Change in VAS Current Pain Score
Average change in self-reported current pain from baseline (screening) to last follow-up visit.
Time frame: Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score
Average AOFAS score
Time frame: Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score
Average AOFAS score
Time frame: Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 7
Time frame: Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 8
Time frame: Up to 52 weeks, post-op
Use of Analgesics
Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Time frame: Up to 52 weeks, post-op
Change in the Use of Analgesics
Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Time frame: Through study completion, an average of 1 year
Ran from Sep 2017 to primary completion in Dec 2018, 15 months.
Of 183 interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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CryoLife, Inc.